School of Science

Department of Applied Science

B.Sc. (Honours) Degree in Pharmaceutical Science Programme Leaders: Dr. Maureen Walsh Ms. Maeve Scott

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Modules for 1st and 2nd year of Pharmaceutical Science degree

Year 1 Year 1

Semester 1 Semester 2

Biology I Biology II

Chemistry I Chemistry II

Physics I Physics II

Mathematics Statistics

Laboratory Practice & Procedures PC Applications

Year 2 Year 2

Semester 3 Semester 4

Organic Chemistry I Pharmaceutical Microbiology

Principles of Biochemistry Pharmaceutical Analysis

Manufacturing Technology I Manufacturing Technology II

Regulatory Affairs Computerised Measurements Systems

Scientific Communications

Industrial Statistics I

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Modules for 3rd and 4th year for Pharmaceutical Chemistry option of the degree

Year 3 Year 3

Semester 5 Semester 6

Organic Chemistry II Work placement (SIPP)

Unit Processes I

Production Management

Aseptic Processing and Utilities

Good Manufacturing Practice

Environmental Health and Safety

Year 4 Year 4

Semester 7 Semester 8

Organic Chemistry III Organic Chemistry IV

Unit Processes II Manufacturing Technology III

Systems Validation Process Control Technology

Project Industrial Statistics II

Project

Modules for 3rd and 4th year for the Biopharmaceutical option of the degree

Year 3 Year 3

Semester 5 Semester 6

Protein Technology Work placement (SIPP)

Pharmaceutical Biotechnology I

Production Management

Aseptic Processing and Utilities

Good Manufacturing Practice

Environmental Health and Safety

Year 4 Year 4

Semester 7 Semester 8

Bioprocess Technology Pharmaceutical Biotechnology II

Advanced Biopharmaceutical Technology Cell Technology

Systems Validation Process Control Technology

Project Industrial Statistics II

Project

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Course Design The programme is of four years duration, with two semesters each year. There is a period of

industrial placement, which begins, in the 2nd semester of Year 3. The course has been

designed to provide increasing emphasis on the technologies of Pharmaceutical and

Biopharmaceutical industries as the course develops.

In the first year, a sound basis is developed in the science subjects – Chemistry, Biology,

Physics, Mathematics, Statistics, Computing and Laboratory Practices and Procedures.

In Year 2, the courses aim to establish the basic Chemistry and Biology material necessary for

more advanced study in subsequent years, and introduces students to topics relevant to the

industrial pharmaceutical environment. Laboratory work is mainly concerned with the

development of manipulative and observational skills and with complementing the theoretical

knowledge learned in the classroom.

In Year 3, the programme will follow two streams, a Pharmaceutical Chemistry stream and a

Biopharmaceutical stream. The content of the courses in each stream will be of relevance to

the respective industry. Some courses such as Good Manufacturing Practice, Aseptic

Processing & Utilities, Environmental Health & Safety and Production Management will be

common to the two streams. An integral part of this year is the industrial placement, where the

student can gain first-hand experience in the application of pharmaceutical technology.

In Year 4, emphasis is placed on more advanced topics in each stream. Some courses such as

Systems Validation, Process Control Technology and Industrial Statistics II are common to

both streams. A major element in the final year is the individual research project that each

student carries out. The project consists of a literature survey on a particular topic followed by

laboratory/pilot plant – based research work on the area of interest. Through laboratory/pilot

plant work and the project, the techniques covered in the programme are reinforced through

interpretation of synthesis, analysis, characterisation, scale-up, and validation.

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Syllabi for Ab initio degree

Pharmaceutical Science

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First Year Syllabi.

Semester One

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SUBJECT TITLE: Biology I SUBJECT CODE: BL11 LEARNING OUTCOMES: A student who has successfully completed this course will: 1. Have a knowledge of basic cell biology including cell structure, function and cell division. 2. Be familiar with mammalian structure and function, including mammalian physiological systems. 3. Have an understanding of environmental biology and contemporary environmental issues. 4. Be able to perform basic biological laboratory tasks including microscopy,

spectroscopy,chromatography and report writing. 5. Be able to perform simple biochemical extractions and analyses. SYLLABUS CONTENT: Total hours: 39 Basic Cell Structure and its Examination Light microscopy, Cell structure and function - Prokaryotic and Eukaryotic cells. Eukaryotic Cell Structure Nucleus, Endoplasmic reticulum, Golgi apparatus, Lysosomes, Microbodies, Energy-related organelles (mitochondria and chloroplasts), Cell-cell adhesion and communication. Cell Membrane Structure and function Cell membrane structure, Lipid bilayers, Protein components, Fluid mosaic models, Cell transport systems. Cell Reproduction and Basic Human Genetics Mitosis and Meiosis; DNA replication; dominant recessive and X-linked inheritance, mutations. Mammalian Physiology Basic tissue types, Mammalian nutrition and digestion, Circulatory system, Immune system, Respiratory system, Excretory system, Sexual reproduction and development, Muscles and skeletons, Nervous system. Introduction to Plant Biology Plant structure, plant nutrition and transport An Introduction to Environmental Biology Food chains, biosphere, environmental concerns Introduction to Bioanalysis Beer-Lambert law, Basic spectroscopy, Introduction to chromatography - TLC / paper. PRACTICAL COURSE: Total Hours: 36 1. Introduction to the biology laboratory - hazard identification / safety considerations. 2. An introduction to the light microscope and the examination of simple cells. 3. Examination of unicellular organisms and microscopic measurement. 4. Diffusion of molecules through a semi-permeable membrane 5. Osmosis in plant and animal cells. 6. Preparation of molar solutions - use of balances and pipettes. 7. Introduction to spectroscopy: Beer-Lambert Law 8. Microscopic examination of different mammalian cell types. 9. Extraction and separation of chlorophyll pigments by thin layer chromatography. 10. The absorption spectrum of a pigment extract. 11. Plant form and structure I 12. Plant form and structure II

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MODULE TITLE: Chemistry I SUBJECT NO. : CH11 LEARNING OUTCOMES: A student who has successfully completed this course will be able to: 1. Distinguish the different types of matter - by state and chemical type - and describe their

properties. 2. Assign the number of subatomic species of each type & the configurations of the early

elements; 3. Predict the formulae of compounds formed by various combinations of elements, name such

compounds unambiguously, and describe the type of bonding involved. 4. Write and balance equations for simple reactions, classify reactions by type, indicate the

states of matter involved, & identify which species (if any) has been oxidised/reduced. 5. Manipulate SI units & use stoichiometry to interconvert mass- and mole-based

quantities, to calculate concentrations, to estimate yields, & to report all such results to an appropriate accuracy.

6. Use the Periodic Table to predict an element’s chemical and physical properties. 7. Describe & measure the heat change involved in a reaction. 8. Predict the equilibrium position of a reaction, & the effect of various disturbances of same. 9. Titrate species by simple volumetric & gravimetric methods. SYLLABUS CONTENT: Total hours: 39 Introduction: Quantities & units in chemistry; SI units; significant figures/decimal places. Atomic structure: Particles: structure & properties; element; metals & non-metals; atomic number & mass number, mass unit; isotopes; anions & cations; introduction to Periodic Table. Compounds: Molecule; molecular & empirical formulae; types: ionic, covalent, acid, base, etc. Formation of Compounds: ionic & covalent; typical chemistry of metals & non-metals; common polyatomic ions; types of reactions: addition, decomposition, acid-base, redox, combustion, etc. Chemical stoichiometry: formulae & elemental composition; equations: balancing, indicating states, ionic & net ionic, etc.; the mole; concentration; molarity; yield. Ionic Compounds: prediction of formulae; nature of bond; solid state structure; ions in solution. Covalent compounds: prediction of formulae; nature of bond; types. Redox reactions: definitions; oxidation number & its calculation; variable oxidation number. Electronic Configurations: quantum numbers; orbitals; rules; configurations of first twenty elements (& their ions); valence shell, octet rule and the Periodic Table; simple Lewis structures. The Periodic Table & Periodic Properties: representative, transition & noble gas elements; ionic & covalent radius; ionisation energy; electron affinity; electronegativity; polar covalent compounds: inter- & intramolecular forces therein; lengths & strengths of covalent bonds. Thermochemistry: heat, specific heat & heat capacity; system & surroundings; calorimetry; endo- & exothermic; enthalpy, important standard enthalpies; Hess’s Law & its applications. Equilibrium: equilibrium constant and reaction quotient; calculation of equilibrium from initial state; Le Chatelier’s Principle; acid dissociation; autoprotolysis of water; pH; buffers. Gas Laws: nature of gas; Boyle’s, Charles’, Avogadro’s, Ideal Laws; kinetic-molecular theory. PRACTICAL COURSE: Total hours: 36 1. Introduction to Chemistry Laboratory (Lab Safety, Chemical handling and Equipment) 2. Gravimetric Determination of the Percentage Hydration in Copper Sulphate. 3. Recrystallisation of Benzoic Acid. 4. Standardisation of Hydrochloric Acid with Sodium Carbonate as Primary Standard. 5. Volumeteric Analysis of a Base Mixture: sodium carbonate/sodium hydroxide. 6. Argentimetric Analysis: measurement of chloride; measurement of halides in sea-water. 7. Volumetric Redox: Standardisation of KMnO4 with Iron (II) Sulphate as Standard. 8. Gravimetric Determination of Nickel via its Butanedione Dioxime complex. 9. Calorimetric Measurement of Enthalpy: solution of salts, acid-base neutralisation. 10. Measuring pH: the pH Meter; effect of dilution on strong acids, weak acids, & buffers. 11. pH Titrations: pKas of Acetic & Phosphoric acids. 13. Revision of Practicals completed and continuous assessment exam.

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SUBJECT TITLE: Physics I SUBJECT NO. : PH11 LEARNING OUTCOMES: On completion of this course students will: 1. Know the basic principles and laws of Mechanics, Fluids, Heat, Waves and Sound so that they can 2. Explain the construction and operation of devices based on these principles 3. Extend these principles to specific applications in Chemistry and Biology 4. Apply these principles to problem-solving situations 5. Have confidence in the use of vernier calipers, micrometer screw gauges, timers, multimeters, solid

state thermal and pressure sensors. 6. Have developed the skills necessary to analyse experimental data SYLLABUS CONTENT: Total Hours: 39 Mechanics S.I. units; vectors; velocity; acceleration; equations of motion; gravity; Newton's laws of motion;

force; weight; momentum; friction; Work; energy; power; conservation of energy; Circular motion; angular velocity; angular momentum; rotation; torque; the couple.

Properties of Matter Tensile stress and strain, elastic and plastic deformation; Hooke's law; Young's modulus; Elastic

potential energy; bulk and shear moduli; Pressure due to a static column of fluid; Pascal's principle and the hydraulic press; Atmospheric pressure; absolute and gauge pressure; the barometer; Streamline flow; Bernoulli's principle and applications; Viscous flow; Poiseuille's equation; terminal velocity; Surface tension; adhesion; wetability; lubricants; capillary rise

Heat Temperature and thermometry; temperature scales; Calorimetry; heat capacity and latent heat;

Kinetic theory; The First Law of Thermodynamics; Thermal conduction; Thermal convection; Thermal radiation; Thermal expansion; thermal stresses; the Gas Laws and absolute zero; Vapour pressure and relative humidity; Diffusion and Osmosis

Vibrations, Waves and Sound Vibrations; natural and forced vibrations; resonance; types of waves; velocity of waves;

wavelength, phase; reflection; refraction; interference; diffraction and polarisation; Characteristics of sound waves; Intensity of sound; environmental limits.

PRACTICAL CONTENT Total Hours: 39 1. Measurement and analysis techniques 2. Measuring instruments 3. The Simple Pendulum 4. Young's Modulus 5. Kinematics Measurements with the Linear Air track. 6. Boyle's law and the Bulk Modulus of Air 7. Relationship between Temperature and Pressure of a gas 8. Determination of the Viscosity of a Fluid 9. Latent Heat of Fusion of Ice and Vaporisation of Water 10. Coefficient of Linear Expansion of a Metal and coefficient of Volume expansion of water 11. Investigation of Thermal Radiation. 12. Properties of Microwaves 13. The Sonometer

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SUBJECT TITLE: Laboratory Practices and Procedures SUBJECT NO. : LPP 11 LEARNING OUTCOMES: A student who has successfully completed this course will: 1. Be aware of safety procedures and personal protective equipment. 2. Be familiar with the identification and handling of hazards in the laboratory. 3. Have gained competency in laboratory calculations involved in preparation of working solutions

from stock solutions. 4. Be able to appropriately select and properly use laboratory equipment e.g. glassware SYLLABUS CONTENT: Total hours: 26 Laboratory safety: wearing/use of proper protective equipment e.g. white coats, safety glasses, masks, gloves. Safety rules; First aid, evacuation procedure, use of fire extinguishers , classes of fires and extinquishers, how to extinguish same, material safety data sheets headings used; Proper carrying of Winchesters and other reagent containers, correct use of fume hoods, safe handling of gas cylinders, chemical spills. Hazards in the laboratory: hazard identification, understanding labels, NFPA hazard diamond, chemical hazards- acids /bases, organics, compatibility, combustion, flash points, biological-infectious /noninfectious wastes cross contamination, aseptic technique, electrical hazards, physical hazards. Risk assessment and hazard identification based on chemistry practical case study. Units of measurement and calculations: moles, molarity, ppm, mg/l, % w/v, dilutions, density, inter-relatedness of units of measurement and conversion from one unit to another. Pure solid, pure liquid, gases dissolved in liquid. Accuracy and precision in measurement, random and systematic errors., significant figures Reagent preparation: procedures for making up solutions, choice of glassware and accuracy, proper use of glass/automatic pipettes, proper use of separating funnels, proper cleaning of glassware and labelling. Waste disposal and chemical storage labelling of waste, segregation of waste, proper storage and disposal, understanding various categories of waste e.g. chlorinated, non- chlorinated, mercury spills disposal, biological waste, autoclaving. Principles of chemical storage, classes of chemicals, correct and incorrect practices; compatibility; segregation Laboratory reports /procedures: report writing, layout, graphs. PRACTICAL COURSE: There will be no stand alone practical element instead it will be integrated and reinforced in other certificate subjects.

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SUBJECT TITLE: MATHEMATICS SUBJECT NO.: MA11 LEARNING OUTCOMES: Having successfully completed this subject the student will be able to: 1 Apply essential algebraic and geometric techniques in the manipulation of scientific formulas

arising in biology, chemistry and physics. 2. Use graphical and geometrical ideas including regression theory to find parameters of experimental laws. 3. Apply the fundamental principles and laws of differential calculus and its uses in finding rates of

change and extrema to problems in the biological, chemical, physical and life sciences 4. Apply techniques of integral calculus and its applications to the calculation of areas and work

done. 5. Solve first order differential equations and interpret solutions when applied in biology, chemistry

and physics. SYLLABUS CONTENT: Total Hours:52 Essential algebraic and geometric techniques Errors and accuracy. Significant figures. Conversion of units. Fundamental algebraic operations. Factoring and fractions. Transposition of formulas. Indices and logarithms. Applications of logs to pH. Linear and log equations in one unknown. Systems of linear equations. Matrix form. Quadratic equations. Applications to equilibrium concentrations. Radian measure and arc length Trigonometric ratios. Solution of right triangles. Sine and cosine rules. Cartesian co-ordinates. Distance between points. Equation of a line. Vectors. Operations with vectors. Dot product. Concept of a function Implicit form. Curve plotting. Verification of experimental laws from graphs of lines. Reduction of non-linear equations to linear form. Properties of trigonometric functions. Applications to functions arising in biology, chemistry and physics. Differential calculus Average rate of change and instantaneous rate of change. Geometric interpretation. Differentiation from first principles. Differentiation of sums, products and quotients. The chain rule. Implicit differentiation. Derivatives of trigonometric functions. Applications to maxima and minima problems. Applications to curve sketching. . Use of software and interpretation of software results. Integration Evaluation of integrals of polynomial, trigonometric, logarithmic and exponential functions. Integration by substitution and by parts. Definite integration. Applications to plane areas. Numerical integration. Trapezoidal rule. Simpsons rule. Use of software and interpretation of software results. Solution of simple first order differential equations Applications to first order chemical reactions, radio-active decay, population growth and decay. Use of software and interpretation of software results. RECOMMENDED LEARNING MODES Lectures and tutorials. Use of computer lab for tutorials on mathematical packages (Matlab)

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First Year syllabi

Semester Two

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SUBJECT TITLE: Biology II SUBJECT NO. : BL12 LEARNING OUTCOMES: On the successful completion of this course, the student will: A.Introduction to Microbiology: 1. Understand the scope of the microbial world and nature of the different microbial types. 2. Have a knowledge of the structure of the procaryotic cell. 3. Understand the importance of, and be competent in aseptic technique. 4. Be able to isolate single colonies of bacteria and carry out various differential staining techniques on

microbial cultures. 5. Be able to prepare and sterilise simple microbial culture media (broths and solid media) and to

pour agar plates. B.Introduction to Biochemistry: 1. Be able to describe the general structure and functions of the major groups of biomolecules. 2. Understand the nature and importance of enzymes as biological catalysts. 3. Be familiar with cellular metabolism. 4. Be able to perform simple biochemical analyses of proteins, enzymes, carbohydrates and lipids. SYLLABUS CONTENT: otal Hours: 39 Introduction to Microbiology The microbial world The nature of micro-organisms: General characteristics of bacteria, viruses, prions and fungi. Procaryotic cell structure An overview of procaryotic cell structure: size, shape and function: arrangement and procaryotic cell organisation. Principles of aseptic technique The concept and importance of pure culture in microbiology. Sterilisation principles The concept of sterility. Sterilisation: principles and methods. Microbial growth Nutrition, culture media, environmental factors affecting growth. Introduction to Biochemistry: Biomolecules Basic structure and functions of proteins, carbohydrates, lipids. Enzymes Classification; Specificity; Effects of temperature and pH on activity. Metabolism ATP as the energy currency of the cell; Glycolysis and Kreb’s cycle.

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PRACTICAL COURSE Total Hours: 36 A. Microbiology: Practicals 1-3. 'Microbes are Everywhere'. Aseptic technique, isolation and maintenance of pure cultures, sterilisation (indicators) and preparation of solid culture media. Colony morphology. Practicals 4-6 Observing bacterial motility, staining microbes. Microscopic techniques for determining culture type. Observing endospores and capsules. Effects of oxygen on microbial growth. Selective and differential media. B. Biochemistry: Practicals 1 - 3: Amino acids, proteins and enzymes: Detection, assay and quantitation. Practicals 4 - 6: Carbohydrates and lipids: Detection and assay. Practical 6: Introduction to chromatography.

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SUBJECT TITLE: Chemistry II SUBJECT NO. : CH12 LEARNING OUTCOMES: A student who has successfully completed this course will be competent to: 1. Name simple organic compounds and draw structures corresponding to names. 2. Describe bonding in saturated and unsaturated carbon compounds. 3. Propose a reaction and synthesis for conversion of one simple organic functional group to another. 4. Identify the factors which affect the rate of a chemical reaction. 5. Perform a synthesis and purification of a simple organic compound. 6. Identify the chemical building blocks of biomolecules. SYLLABUS CONTENT: Total Hours: 39 Introduction to Organic Chemistry; uses; properties of carbon: covalency; the strength of the C-C bond; nomenclature, relationship to biochemistry Alkanes/cycloalkanes; bonding, nomenclature, physical properties, reactions Alkenes/alkynes; bonding, nomenclature, cis-trans isomers, addition reactions Preparation and Identification of Organic Compounds; preparation; separation techniques; purification; analysis; structure determination. Alcohols; OH group, nomenclature, types - primary/secondary/tertiary; bond polarity, H-bonding, effects on properties; simple reactions Aldehydes and ketones; carbonyl group, bonding, polarity and basicity, nomenclature, simple reactions, tests to distinguish aldehydes and ketones Halogen compounds; carbon-halogen bond, reactions Carboxylic acids and esters; H-bonding, preparation of esters, ester hydrolysis. Basic reaction kinetics; reaction rates, order; Amines and amides; structure, identification; Aromatic hydrocarbons; benzene, nomenclature, reactions, some functionalised aromatics; Introduction to Bio-Organic Chemistry; amino acids (L and D forms), peptides and proteins, sugars and carbohydrates, polysaccarides, fats and fatty acids; heterocyclic amines- nucleotides PRACTICAL COURSE: Total Hours: 36 1.0 Introduction to practical organic chemistry; glassware, safety, yield calculations 2.0 Synthesis of aspirin 3.0 Preparation of acetanilide 4.0 Extraction of a two compound mixture 5.0 Isolation of Eugenol 6.0 Kinetics of aldol reaction of acetone and benzaldehyde. 7.0 Isolation of caffeine from tea 8.0 Thin layer chromatography (TLC) 9.0 Fats, oils, soaps and detergents (2 weeks) 10.0 Ketones and aldehydes: tests and characterisation (2 weeks)

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SUBJECT TITLE: Physics II SUBJECT NO. : PH12 LEARNING OUTCOMES: On completion of this course students will know the basic principles and laws of Optics, Electricity, Magnetism, Atomic and Nuclear Physics so that they can: 1. Explain the construction and operation of devices based on these principles 2. Extend these principles to specific applications in Chemistry and Biology 3. Apply these principles to problem-solving situations 4. Have confidence in the use of the spectrometer, oscilloscope, multimeters, Geiger counters. 5. Have advanced their skills in analysing experimental data SYLLABUS CONTENT: Total Hours: 39 Geometrical + Physical Optics The electromagnetic spectrum; Reflection; refraction; Plane mirrors; total internal reflection; fibre

optics; Real and apparent depth; dispersion; Refraction by lenses; the lens equation; lens aberrations; the camera; eye; microscope; telescope. Interference; thin films; Optical Coatings; Newton's rings; Young's slits; diffraction grating; Diffraction limited resolution; the electron microscope;

Electrostatics Charge; insulators and conductors; Coulomb's law; the electroscope; Faraday's cage effect; Hazards

of static electricity in the laboratory; Electric field; electric potential; potential difference; capacitance. Applications of capacitors.

Current, Electricity and Electronics The cell; Ohm's law; Temperature dependence of resistance; superconductivity; Emf and terminal

voltage; Power in electrical circuits; heating effect of an electric current; The Wheatstone bridge; Alternating current; RCL circuits; resonance; Electrical wiring in the laboratory/home; Electric shock and safety procedures; Energy bands in solids, insulators, conductors, semi-conductors; Doping; p.n. junction, diode; rectification; The transistor as an amplifier and as a switch; overview of computer interfacing and A/D, D/A conversion.

Electromagnetism Magnets; Motion of charged particles in electric and magnetic fields; Force on a current-carrying

conductor in a magnetic field; Magnetic field due to a straight conductor, a coil and a solenoid; Electromagnetic induction; Faraday's law; Lenz's law; The dynamo; the generator; the transformer, inductive proximity sensor, relays.

Atomic and Nuclear Physics Atomic structure and transitions; Line and band spectra; Emission and absorption spectra; X- rays;

Photoelectric effect; Lasers; Natural radioactivity and radioactivity series; radioactive decay and half-life; Measurements of radioactivity; dosage units and dosimeters; Environmental limit; disposal of waste; Applications of radioactivity.

PRACTICAL CONTENT: Total hours: 39 1. The focal length of a lens 2. The Spectrometer and diffraction grating 3. Diffraction and optical fibre measurements using a HeNe laser 4. Ohm's law and the Potential divider 5. The Emf / Internal Resistance of a battery and wiring a plug. 6. Measurement of specific heat capacity by an electrical method 7. Thermocouple calibration and determination of the temperature coefficient of resistance of copper. 8. The Wheatstone Bridge 9. Introduction to the Oscilloscope 10. The diode and rectification of AC 11. Transistor transfer Characteristics 12. Radioactivity Measurements 13. Absorption of Gamma rays

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SUBJECT TITLE: PC Applications SUBJECT NO. : PCA12 LEARNING OUTCOMES: Having successfully completed this course, the student will: 1 Know the basic architecture and use of a personal computer and use within a network. 2 Know how to access, source information and retrieve data via the Internet. 3 Be effective and efficient in PC applications packages - WP, Spreadsheet, Database 4 Be able to setup simple databases in Microsoft Access. SYLLABUS CONTENT: Total Hours: 26 Introduction to Computer Technology Types of computer, hardware and software, motherboard, storage devices, input devices,

output devices, memory, system software, applications software, networks and multimedia. Networks

Client Server computing, network topologies, local and wide area networks, connectivity standards, Internet

Introduction to the Internet, searching topics, sourcing information, accessing international databases,

retrieving relevant information, on-line searching. E-mail, browsing the Web, Internet hardware, File

Transfer Protocol, Plug-in and add-ons and Internet security. Word processing

Word processor concepts; -creating new document, entering text, correcting text, formatting, tabs, previewing, printing; Keyboard skills; Correcting and amending text-copy, cut, paste, spell checker, find-and-replace, making tables; Formatting and printing-bold, italic, underline, centring, justifying, borders, fonts, headers, footers; Proof-reading. Graphics.

Spreadsheets Spreadsheet concepts;-design model, enter headings, enter formulae, formatting cells,

entering data; Creating a simple worksheet; Editing-move, copy, sorting; Formatting-column width, number format, bold, italic, underline, alignment; Analysis-"what-if" analysis, graphs; Printing.

Databases Creation, data types, filters, sorting, formulae, report formatting

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SUBJECT TITLE: STATISTICS SUBJECT NO. ST12 Prerequisite subjects MA11 LEARNING OUTCOMES: Having successfully completed this subject, the student will be able to: 1. Collect, tabulate, graph, and summarise data. 2. Recognise simple probability distributions, in particular the binomial, Poisson and normal

distributions, and calculate probabilities associated with them. 3. Draw samples, and construct point and interval estimates of population parameters. 4. Use data to test hypotheses. 5. Construct regression equations, and use the value of a predictor variable to estimate a response. 6. Analyse the variability of data with analytical methods. 7. Understand the application of statistical methodology to real data and interpret the results for

biological, chemical and pharmaceutical data. SYLLABUS CONTENT: Total Hours:52 Data Collection and Organisation Tallies. Frequency tables. Histograms and frequency curves: various patterns and their causes, normal, skew, truncated, bimodal. Time series plots: random variation, trend, shift, cyclical variation. Population and sample. Application of data collection to lab cases. Summary Statistics Mean, median and mode. Range, variance, standard deviation, coefficient of variation. Degrees of freedom. Probability: Definitions of probability. Calculating probabilities. Combinations. Composite events involving mutually exclusive and independent events. Applications in reliability. Probability distributions: binomial, Poisson and normal. Estimation The addition of variances. The central limit theorem. Point estimates and confidence interval estimates of population means. Student’s t distribution. Approximate confidence intervals for population proportions. Application of estimation techniques to lab cases. Hypothesis Testing The reasoning behind a hypothesis test. Hypothesis testing procedure. Tests of population means: one-samplez-test and one-sample t-test. Tests of population proportions. Non-parametric testing: the sign test. Regression and Correlation Scatterplots. Correlation coefficient. Coefficient of determination. Regression equation. Prediction: interpolation and extrapolation. The method of least squares. Use of software and interpretation of software output. Application to lab cases. Analysis of variance. One way and two-way analysis of variance for continuous and categorical data. Types and validity of ANOVA models. Repeated measures designs and other designs such as factorial, hierarchical and unbalanced designs. Use of software and interpretation of software results

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Second Year Syllabi

Semester Three

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MODULE TITLE: MANUFACTURING TECHNOLOGY I SUBJECT NO. : MT21 PREREQUISITE SUBJECTS BL12 LEARNING OUTCOMES: Having successfully completed this subject the student will: 1. Be able to prepare media for a laboratory fermenter 2. Be able to operate a simple laboratory fermenter. 3. Be able to find relevant regulatory issues associated with drug development and release. 4. Be able to screen micro-organisms for selected therapeutic agents. 5. Be able to use a lyophiliser. 6. Be able to differentiate between polyclonal and monoclonal antibodies. 7. Be able to understand the tablet production process. 8. Have a knowledge of routes of absorption of drugs and drug metabolism SYLLABUS CONTENT: 39 hours of lectures Introduction to Biotechnology and Biopharmaceuticals Micro-organisms as a source of therapeutic agents. Vaccine production. Antibiotic production Production of amino acids, vitamins and steroids Introduction to Microbial Fermentation Technology: Control of fermentation process, e.g. aeration, pH, agitation and foam control. Selection of media: Carbon and nitrogen sources. Strain selection and preservation. Antibiotic production and assay. Approaches to improving yields. Use of recombinant microorganisms. Aerobic and anaerobic production processes. Lyophilisation: Applications. Principles. Monitoring the process. Cell hybridoma technology: Monoclonal antibody production.Immobilised enzyme technology. Immuno-diagnostic technology. DNA diagnostic technology & the Human Genome Project. Proteomics and Pharmaceutical Development Bio-Patents and Intellectual Property in Bio-Pharmaceutical Production: Overview of the regulatory issues surrounding development, trial and acceptance of bio-pharmaceuticals. Introduction to Drug administration, absorption and metabolism Introduction to drug absorption, distribution, metabolism and elimination; Routes of administration: oral, inhalation, injection, sublingual, rectal, ocular, topical. Control of oral absorption: gastric motility, particle size, gastric pH, blood flow, enteric bacteria, clearance rate, drug interactions. Drug ionisation: ionisation, pH, absorption of acids and bases Mechanisms of drug absorption – coabsorption with lipids, active transprot , pinocytosis Fate of absorbed drugs: first pass effect Introduction to drug metabolism – overview, function, major sites of drug metabolism, pharmacological activation and deactivation.

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SAMPLE PRACTICALS 36 hours 1. Production of an enzyme in the lab scale fermenter. 2. Optimisation of the yield of the enzyme-media manipulation. 3. Purification of the enzyme. 4. Freeze drying of the enzyme 5. Antibiotic production and the sensitivity of micro-organisms e.g. Penicillin production using

Penecillium chrysogenum 6. Screening of microorganisms for antibacterial peptide production 7. Development of an assay system, e.g. bioassay to assess the level of antimicrobial agent

produced.

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SUBJECT TITLE: ORGANIC CHEMISTRY SUBJECT NO.: OC21 PREREQUISITE SUBJECTS: CH11 & CH12 LEARNING OUTCOMES: Having successfully completed this module, the student will: 1. Understand the effect of chemical bonding on the properties and reactivity of different organic

compounds and their functional groups. 2. Apply the individual properties of the functional groups in organic synthesis. 3. Be able to write simple organic reaction mechanisms. 4. Know the theory behind and factors affecting organic acid & base strengths. 5. Know the criteria for optical activity in organic molecules. 6. Be able to develop basic multi-step syntheses. 7. Be able to carry out basic chemical reactions using the experimental techniques required by a

chemical process development laboratory. 8. Be able to characterise reaction products by physical & spectroscopic techniques (IR, UV).

SYLLABUS CONTENT: Total hours: 39 Organic Molecular Bonding: Lewis structures; hydridisation; polarity. Organic Acids and Bases: pKa’s; resonance, inductive, steric and solvent effects; enolisation; amino acids. Functional Group Reactions & Mechanisms: Alcohols; thiols; aldehydes & ketones; carboxylic acids & derivatives; amines. substitution reactions (SN1 and SN2). elimination reactions (E1 and E2). Aromatics: structures/resonance; substitution reactions - mechanisms and directing groups. Basic Pharmaceutical Pathways: One-step, two-step, three-step routes to pharmaceutical active compounds using functional group interconversions and protecting groups. Organic compounds in 3-dimensions: Conformations of alkanes & cycloalkanes. Optical activity: criteria for isomerism in organic compounds; measurement; optical resolution. PRACTICAL COURSE: Total hours: 24 1. Synthesis of 4-chloro-2-nitrobenzyl bromide (clomipramine intermediate). 2. Synthesis & characterisation of 3-methyl-1-butyl acetate. 3. Carboxylic acid preparation by hydrolysis of a nitrile. 4. Alkyl halides: Structure & reactivity in nucleophilic substititions. 5. Preparation of cyclohexene from cyclohexanol. 6. Nitration of methyl benzoate. 7. Reduction of benzophenone. 8. Chromatographic techniques in Organic Chemistry: separation of pharmaceutical active

compound from an impurity by column chromatography.

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SUBJECT TITLE: PRINCIPLES OF BIOCHEMISTRY SUBJECT NO.: PB21 PRE-REQUISITE SUBJECT: BL12 LEARNING OUTCOMES Having successfully completed this course, the student will be able to: 1. Describe and explain the different levels of protein structure 2. Identify and draw the common amino acids and simple sugars 3. Explain the relationship between protein structure and function and the factors influencing it 4. Describe the basis and applications of different protein, enzyme and carbohydrate assay methods 5. Describe the basis and kinetics of enzyme activity and the factors influencing it 6. Describe the integrated nature of metabolism and its regulation 7. Explain and give examples to describe the basis of cell-cell communications systems 8. Describe examples of commercially important biopharmaceuticals, their applications and production SYLLABUS (39 hours) Introduction to Proteins Amino acids - structures, features, classification / Levels of protein structure, structure function relationships and factors influencing protein structure and stability / How proteins work - Lock and Key mechanisms, Induced fit models / Detection and quantitation of proteins Introduction to Enzymology Classification of enzymes, co-enzymes and co-factors / Michaelis-Menten kinetics, measurements of activity, specific activity, KM and Vmax / Applications of kinetics and the regulation of enzyme activity Introduction to Metabolism Introduction to metabolism, bioenergetics, and metabolic control / Carbohydrate metabolism - microbial and mammalian approaches / Aerobic and anaerobic systems Cell & Human Biochemistry Introduction to cell-cell communications and receptor mediated processes / Peptide, protein and steroidal hormones / Biopharmaceutical protein case studies: colony stimulating factors (e.g. EPO), interleukins (e.g. IL-2), growth factors (e.g. EGF), cytokines (e.g. interferons) - modes of action and biomedical applications Carbohydrates Simple sugars - aldoses and ketoses - structures and chemical characteristics / Complex carbohydrates - starch, glycans, glycosaminoglycans / Glycosylation of proteins - types, functions / Carbohydrates as excipients in protein formulations PRACTICAL COURSE 24 hours 1. Introduction to the biochemistry laboratory - preparation of solutions 2-3 Protein assays - principles / controls / applications / concepts of precision and accuracy 4-5 Enzyme assays - activity / specific activity / kinetics 6 Introduction to protein purification 7 Gel electrophoresis 8 Carbohydrate assays - principles / controls / applications

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SUBJECT TITLE: INDUSTRIAL STATISTICS I SUBJECT NO.: ST21 PREREQUISITE MODULES: ST12 LEARNING OUTCOMES: Having successfully completed this subject, the student will be able to: 1. Apply the fundamentals of experimental design. Develop simple designs, such as randomised and

randomised block designs, and multi-factorial designs with design matrix. 2. Apply statistical process control techniques including process control planning, process capability

and control charts. 3. Understand the importance of reliability and be able to use reliability measurements for the design

and control of processes. 4. Perform sampling, including sample size calculations for continuous and discrete variables.

Interpret various sampling techniques such as random, systematic and sequential sampling. Apply sampling techniques to cases conducted in the lab for chemical, biological and pharmaceutical data.

5. Extract and analyse data from the Pilot plant facility on-line. SYLLABUS CONTENT: Total Hours: 39 Experimental design Development of experimental designs. Simple designs: randomized, randomized block, randomized incomplete blocks. Multi-factor designs: design matrix, full-factorial and fractional factorial design. The case of missing data. Case studies developed with the help of the lab cases. Statistical Process Control Type of data and causes of variation. Control charts fundamentals. Statistical process control planning and construction: the importance of quality planning, identification of product characteristics, definition of measurement systems and construction of charts. Chart analysis: statistical variables, sudden changes, patterns. Process capability: standard deviation analysis, capability indexes, measures for improving capable processes. Reliability Reliability measurements, types of failure, reliability factors, design and modeling reliability, simple and complex component configuration. Sampling. Reasons for sampling, types of sampling: random, systematic, sequential. Sample size as function of cost and availability: equal or unequal variances. Sampling techniques for process control: stratified samples, subgroups. Sample size calculations for continuous and discrete variables and attributes. Methods to define discrimination power and quantify its precision. Statistical methodology behind military standards tables. Application of sampling techniques to lab cases for chemical, biological and pharmaceutical data.

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MODULE TITLE: REGULATORY AFFAIRS SEMESTER MODULE RA21 LEARNING OUTCOMES Students will be able to: 1. Interpret and apply regulatory guidelines to the workplace 2. Carry out regulatory audits of a working environment 3. Identify non-conforming issues and recommend corrective actions 4. Understand the principles of validation and write validation plans 5. Explain the role of the main statutory bodies with responsibility for implementation and

enforcement of environmental legislation 6. Summarise the major Statutory Instruments made under the Safety, Health and Welfare Act, 1989 7. Describe the enforcement procedures relating to the storage and handling of hazardous materials SYLLABUS CONTENT: 52 hours of lectures Regulation & Control of the global pharmaceutical sector Globalisation of the pharmaceutical sector; implications for control of the industry. IMB, EMEA, FDA, Japanese Ministry for Health, National Standards Authority of Ireland (NSAI), EPA and Health and Safety Authority. International Conference for the Harmonisation of Regulations (ICH) ICH: Scope, structure, rationale and authority. ICH guidelines for pharmaceutical production. Mutual recognition policies for the licensing of medicinal products. FDA: Scope and History. Structure of FDA. Authority and areas of activity of FDA. FDA Code of Federal Regulations. IMB: Scope and History. Structure and Authority. Areas of activity; licensing, pharmacovigilance, IMB guidelines. clinical investigations, registration, certificates of sale. Guide to overseas FDA inspections. Guide to IMB inspections . Validation Validation: Definition of The Validation Process. Historical development of validation. Overview of the documentation involved in validation. Validation Master Plans. Validation Protocols. The importance of specifications and limits in validation. Prospective, Concurrent and Retrospective Validations. Pivitol issues in international pharmaceutical regulations The Thalidomide disaster, transmissible retroviral and Spongiform Disease, impact on the industry. Regulatory cases studies from the Irish and US pharmaceutical sector. Guide to licence applications for pharmaceutical manufacture Preparation of New Drug Applications, Abbreviated Drug Applications, Orphan Drugs Applications, and licences for the manufacture of generic drugs. Drug development: Overview of drug R&D and the importance of design controls. Preclinical studies and Clinical Trials (Phase I, Phase II and Phase III) and their role in drug applications. The licencing process, post-market survelliance and adverse event reporting mechanisms. Environmental Legislation The Environmental Protection Agency act. EPA: scope and authority. IPC licencing and waste management principles and regulation. Environmental monitoring requirements for manufacturers of bulk and finished dose pharmaceuticals. Environmental Management systems –ISO 14000 and EMAS. Overview of Irish planning Process and Environmental Impact Assessment (EIA) process and legislation. Preparation and assessment of Environmental Impact Statements (drafts). Health and Safety Legislation Safety, Health and Welfare at Work (SHWW) Act, No. 7, 1989. Secondary legislation – S.I. No. 44 of 1993 (General Applications). Fire & Emergency planning. HSA (enforcement) – Approved Codes of Practice (ACoPs). Hazard identification, risk assessment, and controls (draft safety statement). Storage and Handling of Hazardous materials: Hazardous Chemical Materials - Chemical Agents Regulations 1994; Physicochemical hazards; Toxicological hazards; MSDS; Incompatible materials; Isolation, Separation, and Segregation, Hazardous Biological Materials - Biological Agents Regulations 1998; Classification 1, 2, 3, 4; Controls 1, 2, 3, 4; Ionising Sources – ALARA principle, Ionising Radiation Regulations 1994

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SUBJECT TITLE SCIENTIFIC COMMUNICATION SUBJECT NO.: SC21 LEARNING OUTCOMES Upon completion of the course the student will be able to: 1. Source scientific information effectively. 2. Review and analyse scientific literature and pharmacopaeias 3. Understand and apply citation and referencing methods. 4. Prepare review documents and technical reports. 5. Design a simple experimental protocol 6. Give effective oral presentations. 7. Apply for jobs and prepare for interviews in a professional manner. SYLLABUS CONTENT Total Hours:26 Library and internet resources: Library orientation to include sourcing books and journals. Introduction to library website. Introduction to sources of scientific information on the web; subject guides, search engines. Introduction to scientific journal publications and pharmacopoeias. Overview of key journals in course subject areas. Familiarisation with structure of review and technical scientific publications. Journal papers sourced by students in areas relevant to course work to be read and discussed in group sessions. Familiarisation with Eur. Ph, BP, USP, Martindale. Sourcing information from ISO guidelines, ICH guidelines. Citation and referencing methods Introduction to methods of citation. Student preparation of formatted reference listing from various publications provided. Report writing Literature reviews and guides to compiling relevant information. Organisation of report. Overview of key elements of each section of scientific report. Use of tables, graphs, illustrations and appendices. Student analysis of sections of scientific reports. Understanding documentation procedures. Writing standard operating procedures Basic experimental design Overview of requirements for design of basic experiments based on published methods. Preparation of simple experimental designs to include sample and reagent requirements and time scheduling. Effective Oral presentation skills Preparation of material for oral report. Planning and preparation of effective visual aids. Delivery of an oral presentation. Student delivery of short oral presentation with scientific content. Preparation of curriculum vitae and interview skills Key elements of curriculum vitae – layout and presentation. Preparation for job interviews – sourcing company information – interview technique.

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SUBJECT TITLE: MANUFACTURING TECHNOLOGY II SUBJECT NO.: MT22 PREREQUISITE SUBJECTS: CH11, CH12

LEARNING OUTCOMES: Having successfully completed this subject, the student will: 1. Understand the basic operations involved in the synthesis and purification of chemicals on a large

scale. 2. Have a detailed knowledge of the equipment used in a bulk pharmaceutical plant and its operation. 3. Understand the basic issues associated with scale up, yield optimisation, process safety and

materials & environmental control. 4. Know the grades of water used along with purification procedures. 5. Know how to record data during the manufacturing process. 6. Understand the principles of waste management and control 7. Know and understand the components of formulation and the physical processes of formulation

SYLLABUS CONTENT: Total hours: 52

Chemical Operations in Bulk Pharmaceutical Plants: Plant layout; Organization and functions of each department; Manufacturing records; Batch versus continuous processing. Cost Calculations Unit Operations & Equipment: Reactors – types, uses, limitations, operations such as extractions, sampling, volume measurement, temperature control; scrubbing gaseous byproducts; heating /cooling. Distillation Operations – simple binary, fractional, azeotropic, vacuum, steam stripping, evaporation, solvent recovery. Filtration operations & equipment; Drying operations & equipment. Process Control; Cleaning; Utilities. Mixing/Agitation: operation & types of agitation; flow characteristics; mixing effects/product selectivity. Introduction to the Chemical Aspects of Scale Up: Choice of synthetic route; Environmental issues; Pilot Plants - categories, start-up, safety, feed & product handling, control systems, scheduling. Aims of chemical development, safety considerations, process considerations, telescoping processes, introduction to process optimisation etc Crystallisation and Polymorphism-effects of temperature, cooling, agitation, etc. Characterisation of polymorphs. Thermal Hazard Testing of processes Materials Control: Raw materials; Intermediates; Drug substance; Water systems - types, uses of different water systems and purification processes. Formulation and Tablet Production Active Drug Ingredient and tablet excipients; Production steps for a tablet process: pre-formulation, formulation, milling, blending, drying, granulating, tableting, coating; Preparation of creams and ointments. Testing: dissolution, disintegration testing; Particle size analysis; drug stability studies. Waste Treatment and Management Process waste management requirements; waste treatment and solvent management: sovent recovery and reuse, layout of a typical waste treatment plant – primary and secondary treatment, bacterial conditions, sludge treatment; Process waste minimisation: in batch reactors, during product isolation, fugitive & other minor emissions; Cleaning waste; Environmental protection.

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PRACTICAL COURSE: Total hours: 65 1. HPLC determination of analgesic drug active compounds 2. Use of GC to monitor an esterification reaction. 3. Large scale synthesis of drug active intermediate in 1L lab. Reactor 4. Investigation of the effect of pH and mixing on product selectivity 5. Solvent recovery experiment coupled with GC analysis 6. Waste effluent analysis by ion chromatography 7. Determination of paracetamol / aspirin in a commercial product using UV 8. Industrial visit to Bulk Pharmaceutical Manufacturing Plant. 9. Formulation practical 1: milling and blending 10. Formulation practical II: granulating, drying, tableting 11. Preparation of a cream and an ointment 12. Process simulation and flow sheet design: Pro-designer V4.0 (BatchPro, BioPro, EnviroPro)

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MODULE TITLE: PHARMACEUTICAL MICROBIOLOGY SUBJECT NO. PM22 PREREQUISITE SUBJECTS BL12 LEARNING OUTCOMES: Having successfully completed this subject the student will: 1. Be able to control identify the key growth parameters required by micro-organisms 2. Be able to identify the cause of spoilage of pharmaceutical products. 3. Be able to enumerate micro-organisms. 4. Be able to identify common bacteria. 5. Be able to appreciate the importance of product formulation in terms of control of spoilage. 6. Be able to source and interpret relevant standards. SYLLABUS CONTENT: 39 hours of lectures Microbial ecology and the spoilage of pharmaceutical products: • Requirements for bacterial growth. • Ingredients of pharmaceutical products subject to microbial attack. • Control of spoilage. • Use of preservatives. Introduction to cleanroom technology: • Monitoring of airborne contamination levels. • Viable counts and total particle counts. • Monitoring the performance of a cleanroom. • The sources of contamination and their control. • Introduction to cleanroom standards and cleanroom classifications. Quantification of viable microorganisms: • Use of general purpose selective and differential media. • Introduction to manuals for microbiological media. • Common microorganisms isolated e.g. from water treatment plant and their significance. Identification of common microbial types: • Protocol for isolation of a pure culture. • Aseptic technique. • Use of conventional and rapid methods for isolation of micro-organisms. • Use of laboratory software for identification. Disinfection and cleaning: • Introduction to disinfection action. • Factors affecting potency of disinfectants. • Measurement of disinfectant effectiveness. • Introduction to cleaning validation and its significance. Water as a critical ingredient and source of bacteria: • Impact of treatment on bioburden of water. • Uses of the various classes of water. Microbiological standards in the pharmaceutical industry: • Cleanroom standards. Water quality standards etc.

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SAMPLE PRACTICALS 24 hours 1. Preparation of culture media for the growth of micro-organisms. 2 Introduction to the microbiological quality of water will take place over 3 weeks. 3. The streak plate for isolation of micro-organisms from pharmaceutical products. 4. Aseptic sampling and microbiological analysis of pharmaceutical products. 5. The swab technique for assessing personal hygiene level. 6. Investigation of the source of relevant standards for microbial limits.

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MODULE TITLE: PHARMACEUTICAL ANALYSIS SUBJECT NO. : PA22 LEARNING OUTCOMES: Having successfully completed this module the student will 1. Understand the basic components of a measurement system. 2. Understand the theory of how LC and GC chromatographic systems operate. 3. Understand the processes which can be utilised in attempting to develop and validate an analytical

method. 4. Be able to select the most appropriate method of sample preparation for each spectroscopic technique. 5. Be able to set-up and operate each of the instruments discussed. 6. Understand the accuracy and precision limitations applicable to each technique SYLLABUS CONTENT Total Hours: 39

HPLC • Columns - column packing & construction, sample derivitisation, analytical vs. preparative • Detectors - photometric, photo diode array (PDA), refractive index, IR, conductivity, fluorescence,

electrochemical, hyphenated techniques (HPLC-Mass Spec.) GC • GC - chromatographic principles, instrumentation, pyrolysis & curie-point pyrolysis, sample

derivitisation; columns, gas solid chrom., detectors, quantitative/qualitative analysis (precision, detection limits)

• Method development & optimisation - practical problems; computer operated systems, application in biopharmaceutical analysis

Chromatographic method development & validation • Method development - column selection, use of ion pairing agents, chiral separations, detector

selection, peak purity analysis, elution survey, separation optimisation, qualitative & quantitative analysis, strategic approach to troubleshooting

• Method validation – linearity, LOD, LOQ, column capacity, inter- & intra-assay validation, stability studies (standards & extracted samples), routine validation

• Analysis of biomolecules – stability, purity analysis, proteolysis & protease inhibitors, sample handling & disposal, separation techniques

General Spectroscopy • General principles of Spectroscopy - properties of light, absorption and emission of light, quantitative

laws, instrumentation (sources, monochromators, detection devices) • Ultra Violet-Visible Spectroscopy - introduction, properties, sample preparation, laws, instrumentation,

applications • Infrared Spectroscopy - introduction, properties, sample preparation, instrumentation, applications • Atomic Spectroscopy - introduction, properties, sample preparation, instrumentation, applications Electrochemistry • General Principles - electrochemical cells, equilibrium constants, potentiometric titrations, electrode

potential, types of electrodes, pH and pH meters, cell voltage measurements • Electrochemical Techniques - voltammetry

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EXAMPLE PRACTICALS 24 hours 1. Calibration curve for caffeine and estimation of caffeine in an unknown sample using HPLC 2. Dissolution and HPLC analysis of ibuprofen from a neurophen tablet 3. Quantitative analysis of residual solvents by GC using the method of internal standards. 4. Development and validation of a GC method for the determination of imipramine. 5. Qualitative & quantitative determination of ions in selected samples, using potentiometry 6. Analysis of acetominophen by cyclic voltammetry 7. Structural analysis of unknown solid and liquid samples using Infrared Spectroscopy 8. Spectrophotometric determination of iron in a vitamin tablet

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MODULE TITLE: COMPUTERISED MEASUREMENT SYSTEMS SUBJECT NO: CM 22 Prerequisite Subjects: PH11, PH12, MA11 LEARNING OUTCOMES: Having successfully completed this module, the student will be able to: 1. Describe the structure and operation of components for measurement of flow, level, temperature,

pressure, and density. 2. Explain the installation, maintenance and calibration of these components. 3. Characterize and construct simple computerized measurement systems. 4. Summarize the main types of communication systems used for industrial and scientific

instrumentation. 5. Compare the techniques for measuring flow, level, temperature, pressure, density and evaluate the

advantages and disadvantages of each technique. SYLLABUS CONTENT: 39 hours of lectures Elements of a measurement system: • Basic model. • Static characteristics of measurement systems. • Principles of metrology, calibration and traceability. • Introduction to dynamic characteristics of measurement system. Computerised Measurement Systems: • Model of computerised measurement system. • Basic Computer Architecture. Comparison of PC, Industrial computer, PLC, smart instrument.

Analog v digital. Binary and elementary computer numbers. Digital input output. Analog to digital conversion.

• Characteristics - Resolution. Sampling rate. Nyquist criterion. Digital to analog conversion. Timing/ counting. Outline of real time monitoring and control. Noise & interference. SNR. Amplification. Filtering. Averaging. Isolation.

Sensors / transducers. • Overview of common on-line sensing elements • Density measurement • Pressure measurement • Fluid Flow measurement: Velocity flow across a pipe. Turbulent and Streamline flow. Volume flow. • Mass flow: volume flow and density measurement. • Turbidity, Particle Size Analysis. • Level sensors. • Temperature measurement. Information systems Data acquisition systems: PLC, DCS, SCADA, Batch Management, MRPII, ERP, Production Modelling, LIMS Data Communications • Basic Concepts. Serial, parallel and network communications. • Overview of Common computer communications protocols. • Data Communications for measurement and process control. • Process and Instrumentation Diagrams. • Communications protocols at sensor/transducer level and at instrument level. • Introduction to passing data between applications.

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PRACTICAL COURSE: Total hours: 24 1. Introduction to digital I/O. Sensors as switches. 2. Nyquist Criterion – How often should one sample. 3. Resolution. Calibration of ADC and sensor system. 4. Construction & implementation of PC based measurement & control system. 5. Controlling instruments through the serial port /IEEE 488 bus. 6. Use of smart sensors to measure flow/ temperature & communication with PC 7. Use of optical and chemical sensors for online monitoring. 8. Online monitoring & passing of data to database system.

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Third Year Syllabi

Semester five

Common subjects

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MODULE TITLE: GOOD MANUFACTURING PRACTICE SUBJECT NO. : GMP31 LEARNING OUTCOMES: Having successfully completed this subject, the student will be able to: 1. Outline the necessity and function of GMP regulatory control bodies within industry. 2. Understand the principles of Good Manufacturing Practices and be able to apply them to an

industrial environment. 3. Work under controlled conditions with documented procedures. 4. Write a Standard Operating Procedure. 5. Write a calibration procedure and carry out a calibration of a simple item of equipment 6. Write a validation plan and carry out validation of an analytical system / method. 7. Understand and write sampling plans, and be able to use ANSI sampling tables. 8. Identify the steps involved in a GMP inspection. 9. Identify the impact of relevant quality systems on day to day activities in the workplace.

SYLLABUS CONTENT: 26 hours lectures GMP/c-GMP • Introduction to GMP • Regulatory Agencies • Hygiene • Dress Code • GMP Goals GMP Intermediates • SOPs • Records and Logbooks, e.g. Batch Manufacturing Records, calibration records, maintenance

logbooks • Personnel and Training • Warehousing • Cleaning Building – Finished • Cleaning Equipment • Manufacturing Routine –Bulk and Finished dose • Packaging Routine – Finished dose • Labelling – Process, cleaning, calibration • Out of Specification results - OOS investigations, deviations • Stability studies – Product stability, stability specifications, testing intervals, failures • Retraining/Reinforcing GMP GMP and Calibration • GMP requirements for equipment and machinery calibration • Developing calibration plans, calibration procedures, calibration reports.

Validation • Validation Protocols, Qualification, validation of analytical system • Validation of Analytical Methods e.g. HPLC Control of incoming materials • Normal, tightened, reduced inspection. Use of ANSI Standard Tables GMP Compliance Audits and Inspection • Overview of steps involved in GMP audits. • Complaints/Recalls Quality Systems: ISO 9000, TQM, World class Manufacturing, Just in Time

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PRACTICAL COURSE: 12 hours As part of this course students will undertake a mini-project in the laboratory or pilot plant facility. This will involve the production of a range of GMP documentation such as SOP’s, calibration records, BMR’s, maintenance logs, cleaning logs, complaint reports, validation master plans, validation protocols, validation reports. Training records for students will be established and will be updated as new skills are learned in other modules. All documentaion developed will be applied in other modules. Topics which the mini-projects might be based on include: 1.0 Writing SOPs for simple chemical equipment and processes 2.0 Developing calibration schedules for and calibrating equipment used in working environment 3.0 Validation of an HPLC system 4.0 Validation of a UV spectrophotometer 5.0 Validation of an Analytical method – HPLC, GC

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SUBJECT TITLE: ASEPTIC PROCESSING AND UTILITIES SUBJECT NO. AP31 PREREQUISITE SUBJECTS MT21, MT22, PM22 LEARNING OUTCOMES: Having successfully completed this subject the student will: 1. Be able to determine airborne particle counts and air velocities. 2. Be able to partially validate HEPA filter integrity. 3. Be able to partially validate a water treatment system. 4. Be able to implement contamination control procedures. 5. Be able to validate a moist heat steriliser. 6. Be able to interpret cleanroom validation data. 7. Be able to access relevant regulatory requirements using the internet. 8. Be able to isolate and identify common spoilage micro-organisms. SYLLABUS CONTENT: 39 hours of lectures Heating Ventillation and Air Conditioning, (HVAC): High efficiency particulate air (HEPA) filtration. Design and construction. Air flow direction, air flow rates. Room air pressure and air changes. Room air pressure differentials. Temperature and humidity control. Warning limits. Pharmaceutical Water Systems: Water treatment systems, USP, purified water , water for injection, (WFI), rinse water. Impurity testing. Purification methods. Microbiological assay: Bacterial endotoxins, bioburden recovery. Microbiological and chemical standards. Alert and action levels. Water pre-treatment, treatment and purification systems. FDA rules and regulations as regards pharmaceutical grade water. Water storage, water pumps , piping systems storage vessel construction, heat exchangers. Validation of pharmaceutical water system: Documentation, change control, validation report, sampling plan and frequency of tests. Establishing a maintenance programme. Self audits of the water system. Aseptic Processing: Microbial Ecology and Spoilage of Pharmaceutical Products: Main ingredients subject to attack. Factors controlling rate of spoilage. Opportunist and acute pathogens. Observable effects of spoilage. The use of preservatives. Environmental monitoring and control. People as a source of contamination. Disinfection and its validation. Cleaning systems e.g. CIP. Cleanroom Technology: Control of contamination by using cleanrooms. Personnel gowning requirements. Cleanroom design and construction. Cleanroom classification. Cleanroom configuration. Measurement of viable and non viable particles. Conformance to standards. Clean in place technology and validation of CIP: Aseptic work practices. Aseptic packaging technology. Aseptic filling. Media fills. Evaluation of vial closing integrity. Microbiological evaluation. Automated microbial identification systems. Pyrogens and depyrogenation. Isolation technology: Design, construction and testing. Applications. Validation. Microbiological evaluation. Regulatory requirements. Absolute enclosed and partial barriers. Design of barrier enclosure. Handling techniques. Sterile air. Sterile transfer technique. Enclosure sterilisation. Validation of enclosure integrity. Sterile production cycle. Packaging. Personnel protection. Lyophilisation.

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Sterilisation Methods: Moist heat, dry heat, gaseous, irradiation. Fluid sterilisation by filtration, filter construction, filter integrity, the bubble point test. Filtration capacity and efficiency. Sterilisation in place (SIP). Steam in place. Sterility testing: Limitations. Bioburden control. Process validation, validation protocol. Validation requirements, daily quarterly and yearly testing requirements. Biological chemical and physical indicators. Container mapping studies. Heat distribution studies using thermocouples. Sterilisation standards and Regulatory Requirements: Regulatory requirements. Bacterial contamination of stainless steel equipment. Pyrogens and depyrogenation. Limulus Amebocyte Lysate Testing. Robotic applications in sterility testing. Reducing the risk of viral tranmissions in products. Sample Practicals 24 hours of practicals Practicals 1-3, 6 & 7 will be carried out in the pilot plant facility, while the remainder will take place in the laboratory. 1. HEPA filter integrity-air velocity measurements and settle plates 2. HEPA filter integrity –measurement of the number of particles. 3. Water treatment system partial validation-isolation of bacteria from untreated/treated water 4. Isolation of micro-organisms from pharmaceutical products. 5. Identification of spoilage micro-organisms from pharmaceutical products. 6. Cleaning system evaluation-rinse and swab methods. 7. Steam in place validation –destruction of thermophilic bacteria. 8. Evaluation of disinfectants-static/cidal effect, recovery of stressed cells

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MODULE TITLE: PRODUCTION MANAGEMENT SUBJECT NO. : PM31 LEARNING OUTCOMES: On successful completion of this Module the student will: 1. Be capable of identifying the adaptation of marketing practice that may be required for services. 2. Understand and apply the concepts involved in operations management. 3. Appreciate the importance and applications of budgeting and costing techniques. 4. Evaluate the various strategic options available in terms of their appropriateness to the organisation. 5. Identify the links between the organisation’s structure and its strategy. SYLLABUS CONTENT: Total: 39 hours Management Principles: Management defined, management theories, the job of the manager in an everyday context, job design, co-ordination, span of control, centralisation, line and staff functions, standardisation, formality, basic structural formats. Assessing staff performance, developing /training employees, building and evaluating career performance, career planning and goal setting, job progression and career decisions. Risk management and trouble shooting. Production Planning: Forecasting, Capacity Planning, operations scheduling, aggregate planning, master Production schedule , Rough cut Capacity planning), Project planning, MS Project Inventory & Quality Management: Independent demand - how much to order (EOQ), when to order, dependent demand - material requirements planning, Just-In-Time production, scheduling methods, scheduling activities, scheduling by type of operation - job, batch, continuous, defining quality, Total Quality Management, quality in manufacturing/service systems, measurement, process management/continuous improvement, evaluation and assessment. Defining and measuring capacity, system effectiveness, capacity strategies, detailed capacity planning. Budgeting & Costing: Budgetary procedures including master and subsidiary budgets, fixed and flexible budgets under conditions of uncertainty and the behavioural aspects of budgets. Cost ascertainment to include coding and classifying costs, cost units and cost centres, allocation and apportionment, direct and indirect costs. Absorption costing, investment appraising.

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SUBJECT TITLE: ENVIRONMENTAL, HEALTH & SAFETY SUBJECT NO.: EHS31 LEARNING OUTCOMES: Having successfully completed this subject the student will be able to: 1. Recognise and evaluate health hazards in the workplace. 2. Identify control strategies that will reduce health risks to acceptable standards. 3. Understand the effect specific hazards have on health and safety and necessary controls. 4. Understand the effects of toxic insults on the body, their causative agents and resulting occupational

diseases. 5. Understand and have a knowledge of a number of environmental systems 6. Have a detailed knowledge of the sources of pollution 7. Understand the biological monitoring of these systems 8. Assess the factors that affect the efficiency of water and wastewater treatment. 9. Evaluate options for using biological technologies treat organic wastes.

SYLLABUS CONTENT: Total hours: 26 hours Occupational Hygiene Recognition – Different classes of environmental stress Evaluation – Environmental measurement techniques, Interpretation of results, e.g. Threshold limit values (TLV), Maximum Exposure Limits (MEL), Occupational Exposure Limits (OEL); skin absorption; carcinogens. Control measures – Specification, substitution, segregation, local exhaust ventilation, general dilution ventilation, good housekeeping/personal hygiene, reduced time exposure, personal protection. Control of Specific Hazards Dust – irritant, respiratable, carcinogenic, explosive. Electricity – Static electricity, protective/safety controls, electrical equipment in flammable atmospheres and wet environments – classifications 0, 1, 2; low and high tension sources (LT and HT). Noise and Vibration – Sound and noise, measuring noise level, the ear and the effect of noise on the ear, noise, control techniques – e.g. silencers, lagging, damping, personal protection; effect of vibration on human body (VWF, WBV), machinery vibration Heat &cold Stress – measurement, body reaction, controls Radiation – Non-ionising – types, controls; Ionising – sources, exposure limits, controls Manual Handling – architecture of the spine, proper manual handling procedures Occupational Diseases Diseases of the skin – dermatitis (irritant contact and allergic); Diseases of the respiratory system – asthma, fibrosis; Noise induced hearing loss; Raynauds Syndrome; Chlor acne; Central Nervous System (CNS) depression. ENVIRONMENTAL Waste Stream Management Air pollution- sources; definition of an air pollutant, Reactive gases and residence time in atmosphere. Biological air pollutants. Air monitoring: air monitoring categories. Air pollutant categories. Monitoring strategies, initial assessment and survey. Sample collection devices. Air sampling programmes Water pollution: Definition of water pollution. General classification and description of causes of water pollution. Waste prevention, minimisation and recycling. Major quality parameters for analysis of wastewaters and sludges. Outline of treatment requirements to prevent water pollution. Waste Treatment & Management: Biotreatment of organic wastes, reduction of pollution potential coupled to production of biofuels. Waste Management Planning – National/Regional Planning, Waste management Strategies and Plans and associated legal issues. Overview of options available: recycling, reuse; Incineration and associated Technologies; Landfill – impacts including leachate, landfill, gas, etc; Site selection criteria and assessment criteria; site operation, site monitoring and site decommissioning.

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Third Year Syllabi

Semester five

Biopharmaceutical Science Option

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MODULE TITLE: PHARMACEUTICAL BIOTECHNOLOGY I SEMESTER MODULE PB31 PREREQUISITE SUBBJECTS: PB23, MT21 LEARNING OUTCOMES: 1. The student on completion of this module should be able to: 2. Carry out basic nucleic acid manipulation and analysis 3. Perform a cloning experiment in a prokaryotic system 4. Perform and optimise PCR amplification of DNA 5. Understand the practical issues involved in large-scale production of recombinant proteins using

prokaryotic, animal and plant systems 6. Have a knowledge of the GMO regulatory policy in Ireland SYLLABUS CONTENT: Hours: 39 hours of lectures Biotechnology in the Pharmaceutical Industry – Pre-biotechnology products, impact of biotechnology, post-biotechnology products Fundamentals of Pharmaceutical Biotechnology Genetic manipulation methods; Basic cloning techniques; Principles of PCR Production of pharmacologically relevant proteins using Prokaryotic systems Applications of Biotechnology in Industrial fermentation processes Genetic manipulation of industrial micro-organisms; recombinant stability, product expression, yields. Production of pharmacologically relevant proteins using Animal systems Fundamentals of recombinant DNA techniques in animal cells; Large-scale production of recombinant proteins using animal cell systems; Applications of animal cell systems in pharmaceutical industry Production of pharmacologically relevant proteins using Plant systems Fundamentals of recombinant DNA techniques in plant biotechnology, Large-scale production of proteins using plant biotechnology; Applications of plant biotechnology in pharmaceutical industry.

Production of antibody-based diagnostics and therapeutics in Pharmaceutical Industry Production of recombinant monoclonal antibodies; Large-scale antibody production; Immunotoxins; Chimeric antibodies; Antibody fragments. Regulation of Genetically Modified Organisms GMO policy in Ireland; role of EPA, HSA and FSAI; role of EU commission Recent innovations in Pharmaceutical Biotechnology Emerging technologies; topics from current research publications

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SAMPLE PRACTICALS: Total hours: 24 Practicals 1-3: Basic recombinant DNA techniques Restriction digestion of DNA AGE and UV analsysis of DNA preparations Vector DNA isolation Practicals 4-6: Cloning in Prokaryotic system Prokaryotic vector and host system. Transformation by electroporation and heat-shock. Analysis of transformants using antibiotic resistance markers Practicals 7-8: DNA amplification by PCR Amplification of cloned DNA insert from vector. Optimisation of amplfication reaction. Analysis of amplicons using AGE.

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SUBJECT TITLE: PROTEIN TECHNOLOGY SUBJECT NO. : PT31 PRE-REQUISITE SUBJECT: PB23 LEARNING OUTCOMES • Having successfully completed this course, the student will: • Be able to describe in detail the structure-function relationship in proteins and factors influencing it • Be able to describe the principles, applications, and limitations of various protein separation

techniques • Be able to analyse and monitor the purification of proteins/enzymes • Have demonstrated a technical competency in the performance and use of protein purification and

analysis tools/equipment • Be able to describe modern approaches to vaccine design and production SYLLABUS 39 hours of lectures The biochemistry of proteins • Review of protein structure and structure activity/function relationships Protein Isolation & Purification • Protein characteristics exploited in protein isolation and purification • Protein extraction techniques – cell (microbial, yeast, plant and animal) disruption techniques • Protein concentration techniques – precipitation / salting-out / ultrafiltration • Protein separation techniques – chromatographic (size-exclusion / ion-exchange / affinity /

hydrophobic interaction) and electrophoretic (preparative and analytical -polyacrylamide / SDS / isoelectric focusing / capillary electrophoresis)

• Protein identification and purity determinations – FDA perspective / analytical methods / bioinformatics

• Design and evaluation of purification strategies • Biopharmaceutical protein purification case studies • Impact of new technologies Protein stabilisation • Protein denaturation and inactivation proceses • Strategies to improve stability - use of excipients / chemical cross linking / thermophillic proteins /

recombinant approaches Vaccine Development • Introduction to the immune system • Requirements for effective vaccines • Attenuated organisms as vaccines • Impact of recombinant DNA technology on vaccine development • Case studies: AIDS vaccine / malaria vaccine / cancer vaccines • Vaccine formulations and adjuvants PRACTICAL COURSE: 24 hours 1 Protein assays 2 Enzyme assays - activity and specific activity measurements 3-4 Protein concentration techniques - ammonium sulfate precipitation / ultrafiltration 5-7 Chromatographic techniques for protein purification - Gel filtration / Ion-exchange salt gradient

elution / Affinity chromatography / Protein A chromatography 8 Evaluation of protein purity - SDS-PAGE / HPLC

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Third Year

Semester Five

Pharmaceutical Chemistry Option

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MODULE TITLE: ORGANIC CHEMISTRY II SUBJECT NO. : OC31 PREREQUISITE SUBJECTS: OC21 LEARNING OUTCOMES: Having successfully completed this module, the student will: 1.0 Understand the key reactions of alkenes and alkynes 2.0 Understand the reactions of the carbonyl group 3.0 Know the reagents used in major functional group transformations 4.0 Understand the concepts of condensation reactions 5.0 Know the names and reactivity of simple heterocyclic compounds 6.0 Be able to understand the various concepts of stereochemistry 7.0 Understand the relationship between the mechanism of a reaction and the product

stereochemistry SYLLABUS CONTENT: 39 hours Important reactions of alkenes and alkynes: Oxidation of alkenes – Diols, Epoxidations, Ozonolysis, etc. Diels-Alder Reaction – Dienes, dienophiles, mechanism, stereo outcomes. Reduction of Alkynes – Addition; Hydrogenation over Pt/C or Lindlars catalyst and dissolving metal reductions (free radical mechanism). Reactions at the Carbonyl Group: Grignard and Reformatsky reactions (cuprates); Acetals and Ketals Organolithium reagents and enolate anion reaction: Organolithium reagents (n-BuLi and LDA, LiHMDS, etc) Kinetic V Thermodynamic enolate ions; Alkylation reactions. Condensation reactions: Aldol, Claisen, Dieckmann (decarboxylation reactions), Knoevenagel, Michael Addition, Choice of condensation reactions. Introduction to heterocyclic compounds Saturated – Ring opening of oxiranes and aziridines Aromatic Heterocycles – Pyrrole, furan, thiophene, pyridine and their reactivities compared to carbocylic rings; Electrophilic addition reactions; Nucleophilic Aromatic Substitution. Biologically important heterocycles. Stereochemistry Enantiomerism, tetrahedral carbon and optical activity;Newman projections, Stereogenic centres R- and S- sequence rules/Fischer projections; Enantiomers, Diastereomers and Meso forms Resolution of racemic mixtures Regioselective, stereoselective and stereospecific reactions, Stereochemistry and mechanism of syn- and anti-additions, Stereochemistry of syn- and anti-elimination reactions : PRACTICAL COURSE Total Hours: 24 1. Preparation of 4-Bromobenzophenone by the Friedel-Crafts Reaction 2. Acetal Formation using ethylene glycol 3. Preparation of 4-Vinylbenzoic acid by a Wittig reaction in an aqueous medium 4. Aldol Condensation Reaction: Reaction of Benzaldehyde and Acetone 5. Column Chromatogrphy: Separation of Products from the Acetylation of Ferrocene (3 weeks

duration) 6. Preparation of Benzylidene-D-Mannitol 7. Oxidation and Epimerisation of (-)-menthone 8. Diels-Alder preparation of cis-cyclohex-4-ene-1,2-dicarboxylic acid

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MODULE TITLE: UNIT PROCESSES I SUBJECT NO.: UP31 PREREQUISITE SUBJECTS LEARNING OUTCOMES: Having successfully completed this module, the student will: 1. Be able to identify what factors affect equilibrium constants and predict the extent of a reaction. 2. Be competent in the determination and interpretation of kinetic data. 3. Understand the relevance and application of thermodynamics to chemical systems. 4. Learn the basis types of crystals and their morphology SYLLABUS CONTENT: Total hours: 39 Chemical Equilibrium: Properties of equilibria; determination of equilibrium constants; Le Chatelier’s principle; factors which affect equilibrium; sparingly soluble solids; solubility products and saturated solutions; acid-base theory; determination of Ka and pKa; buffers, Henderson-Hasselbalch equation; partition coefficient; application to equilibrium reactions to pharmaceutical systems. Kinetics: Rate, order and rate constant of a reaction; differential and integrated rate equations; half life; methods to find the order and rate constant of a reaction, pseudo first order kinetics; experimental techniques applied to kinetics, sampling and continuous methods; factors which affect rate, temperature, concentration etc.; Arrhenius equation and activation energies; introduction to multi-step reactions and reaction mechanisms, molecularity, elementary processes and rate-determining step; study of pharmaceutical reaction kinetic problems. Chemical thermodynamics: Systems; surroundings; equilibrium states; state functions; internal energy,work and heat; first law of thermodynamics; enthalpy; thermochemistry; standard states; bond energies; Hess’s Law; heat capacity; reversibility and spontaneity; entropy and the second law of thermodynamics; absolute entropies and the third law; free energy; free energy and equilibrium constants. Physical properties of crystals Fundamentals of Molecular Crystals. Structure of Crystalline Solids, Close Packing principle, Line group and plane group symmetries, space groups symmetry, and forces in Molecular crystals, polymorphism, crystal engineering. Symmetric synthesis in crystals, Homogenous and heterogeneous Thermal Reactions, enantioselective reactions, crystal growth, Crystal nucleation

SAMPLE PRACTICALS: Total hours: 24 1. A kinetic study of ester hydrolysis by conductometry. 2. Determination of the rate constant for the iodination of acetone by spectrometry. 3. Determination of order and rate constant for the oxidation of iodide by persulphate. 4. Solubility and enthalpy of solution of oxalic acid in water. 5. Determination of the ionisation constant of bromophenol blue 6. Determination of the limiting molar conductance of NaCl and KCl. 7. Determination of the equilibrium constant for the keto-enol tautomerism of

acetylacetoacetate 8. Study of the equilibrium reaction between the iron (III) ion and the thiocyanate ion

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Third year

Semester Six

Common

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MODULE TITLE: Industrial Placement SUBJECT NO .: IP32 ACCS CREDITS: 30 AIM The aim of the Industrial Placement is to enable the student to integrate classroom theory with practice in a work environment within the pharmaceutical sector. It will introduce the student to structured employment and will develop in the students an understanding of the organisation, its procedures, good manufacturing practice and technology. LEARNING OUTCOMES The student will be able to ! Understand and describe Good Manufacturing Practice and Technologies as implemented

by the host enterprise. ! Understand and describe the quality assurance requirements, control and practice in the

host enterprise. ! Understand and describe the importance of safety in the workplace and describe the safety

procedures in operation in the host enterprise. ! Describe the manufacturing and production practices within the host enterprise and

describe the process equipment used. ! Understand and describe the Information Technology utilized within the sector of the

industry, in which they worked. ! Perform the practical skills determined by the host company, as being appropriate for its

particular requirements. ! Keep a record of activities while in placement, utilizing log book. ! Prepare a Placement Report.

General: The industrial placement involves a partnership between the employer, the student and the Institute. The functions carried out by the student, while in placement will be structured and commensurate with the Aims of the placement. The industrial placement takes place over 6 months from February to August inclusive. Management: • The Industrial Placement Co-ordinator will be responsible for the management of the

industrial placement programme. This includes organising placement workshops for all students due for placement. The workshops will cover all aspects of the placement, such as policies and procedures of placement, advice/assistance in compiling CVs, interview skills and assessment procedures.

• An Academic Tutor is allocated to each student for the duration of the industrial placement. • A work programme will be agreed between the industrial supervisor and the academic tutor

in consultation with the student. • The tutor will monitor the student’s progress by maintaining close contact with the student

and the industrial supervisor. • Students will be visited twice during the placement, once after two months and once before

leaving. Selection and Placement procedure: • Job descriptions are submitted by placement industries to the Industrial Placement Co-

ordinator. • Allocation of industrial placements is based on standard CVs submitted by the students.

CVs are matched to the job description and are sent to the industries. They then select the

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students whom they wish to interview and notify the Industrial Placement Co-ordinator and interviews are arranged.

• Students are expected to attend interview and to accept the first placement offered. • Students may seek their own industrial placement but must inform the Industrial Placement

Co-ordinator immediately on securing a position, in order for it to be assessed and approved as being suitable and relevant to the academic programme.

Assessment: • The student is required to keep a log book detailing their daily activities. This is signed by

the industrial supervisor at the end of the placement. • The student is required to submit a report on their placement to the employer and their

academic tutor. This report will normally include the following however the level of content detail is at the discretion of each industry:

" Title page " Placement objectives " Summary of the placement " Background of the company, including management structure and operation " Training and development programmes undertaken " Student’s role during placement, duties performed, experiences / lessons learned " Overview of equipment and materials used " Conclusions • The industrial supervisor completes a Student Evaluation form giving details on the

student’s performance. This form is returned to the Industrial Placement Co-ordinator for examination by the External Examiner. It also acts as a source of feedback on the industrial placement programme.

• The assessment will be based on: " Report(s) from the academic tutor " A Student Evaluation Form from the industrial supervisor " Student Log book " Written report • The industrial placement performance of each student will be presented on a

satisfactory/completion basis i.e. pass/fail and will not affect their credits or GPA. If a student fails to secure an industrial placement a research project is offered as an alternative. As far as possible the project offered will be of an industrial nature and will involve the use of the pharmaceutical pilot plant facility. Where this is not possible/appropriate, projects in line with current research within the Department may be provided. Each student will be assigned a supervisor for the duration of the project. The project will be assessed under the following headings: " Written report including literature survey " Oral Presentation " Continuous Assessment The written report must be submitted by the beginning of the next academic year. The oral presentation will involve preparing a seminar of a 10-15 min duration and will be attended by at least two teaching members of staff and by the student’s in the class. The students will be assessed on a pass/fail basis and their credits or GPA will not be affected.

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Fourth Year

Semesters Seven and Eight

Common

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MODULE TITLE: SYSTEMS VALIDATION SUBJECT NO. : SV41 PREQUISITE SUBJECTS: GMP31 & RA21 LEARNING OUTCOMES: Having successfully completed this subject, the student will be able to: 1. Understand of the need for validation 2. Define validation systems and associated regulatory requirements 3. Analyse and Validate selected pharmaceutical equipment 4. Analyse and Validate selected pharmaceutical tablet processes 5. Validate a Bulk Pharmaceutical Process 6. Validate cleaning procedures for pharmaceutical equipment 7. Validate a water purification system 8. Define the core regulatory guidelines governing use of computerised systems 9. Contribute to the validation of computer and automated systems from a user perspective 10. Draft validation plans and protocols 11. Understand, structure and write validation reports SYLLABUS CONTENT: 39 hours lectures Validation and Documentation • Validation Masterplan, Product Development Report, Design Qualification, Installation

Qualification, Operational Qualification, Performance Qualification, Validation report

Validation reports • Structure, Interpretation • Common Problems Validation of Utilities • Water purification system • Ventilation systems Process Validation • Bulk – Drug master files, Technology transfer, Change Control, Critical steps • Validation of Sterile BPCs. • Finished - milling/blending/compression and coating • Case Studies Cleaning and Sterility Validation • Protocol • BPCs, Pharmaceutical equipment, filling –line, clean-room and air supply. • Dry heat, Moist heat, Gaseous sterilants, radiological methods of sterilisation. • Statistics • Cleaning and disinfecting technologies – chemical agents and physical techniques

Computer Validation and Automation Validation • Regulatory Standards and Guide lines: EU GMP Annex 11, FDA CFR 21 part 11, GCLP, (OECD),

GALP (USEPA). • V model. Roles. Change control. • Requirements analysis and specification (FDS). Top level design and specification. • S.D.S. Software Development. Detail design and specification. Coding. • Module Testing. Integration Testing. System Testing. FAT. SAT. • Documentation. • Ongoing validation and maintenance. • Case studies – Good Practice Examples

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PRACTICALS 36 hours As part of this course students will carry out a mini-project involving the validation of a process or element of a process. This project will be based in the pilot plant. It will require production of a set of validation documentation as well as actual qualification of a piece of equipment or processes. At the end of the semester students will be required to give a presentation on their validation mini-project. Topics which might fall into this area include: 1. Validation of a water purification system 2. Validation of a CIP tank 3. Validation of a pharmaceutical process 4. Validation of a Biopharmaceutical process 5. Validation of pharmaceutical equipment – v-blender, tablet press, friability tester 6. Validation of a Fermenter 7. Validation of a Cleaning Procedure for a v-blender 8. Validation of on-line instrumentation – pH, pressure meters, flow meters 9. Validation of software

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SUBJECT TITLE STUDENT PROJECT SUBJECT NO.: SP41 CONTEXT A major project is seen as an ideal ground in which the student as an individual can demonstrate the full range of his/her personal skills. The successful completion of a project requires that the student draws fully on his/her knowledge, conceptual and technical skills. Here, the project will provide the student with the opportunity to develop and demonstrate his/her individual skills in the research, design, implementation and interpretation of a substantial body of scientific work. The performance of such an individual literature and practical research project is highly regarded in the evaluation of any science graduate. LEARNING OUTCOMES: On successfully completing this module, the student will: 1. Have researched and presented a major review of a given topic; 2. Have undertaken the design and implementation of a major body of pilot plant-based,

laboratory-based experimental or validation work; 3. Have demonstrated and implemented individual skills in terms of self-motivation, planning

and creativity in a technically challenging project; 4. Have demonstrated a detailed understanding of the underlying concepts to, and the

rationale behind the use of a variety of techniques and process development. PROJECT STRUCTURE All students must complete a substantial project as part fulfilment of their degree studies. The project will be divided between semesters 7 and 8 and is to be assessed as a complete module at the end of semester 8. The projects will be carried out in the pilot plant facility, as much as is possible. The project should provide the student with the opportunity to demonstrate a significant element of self-motivation and creativity in terms of the design and execution of their given area of study. The structure of the project will involve a number of elements designed to draw on the full range of the students skills. Semester 7 will focus on three elements: • the preparation of a major review of the current literature in a given area; • to design a programme of experimental work consistent with the goals of their given

project; • the presentation of written and oral reports based on this work. In semester 8, students will use the experimental plan designed in semester 7 as a blueprint for their project work. They will have 8 to 10 weeks available to them for completion of this work (equivalent to approximately 170 hours in the pilot plant facility). At the end of this time, a final written report must be presented together with an oral presentation.

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Semester 7: Literature review and project design In semester 7, each student will conduct an in-depth study of a particular area of pharmaceutical or biopharmaceutical science. This will provide a detailed background and introduction to their semester 8 experimental work. The review will include: ♦ an in-depth analysis of the history and current status and trends in a topical area in

pharmaceutical or biopharmaceutical science; ♦ a detailed experimental strategy for the completion of their given experimental project

including time and resource management, method selection, method validation, data analysis, safety considerations in the laboratory.

Students will be required to prepare a type-written review in a style and format appropriate to that used in scientific journals. A 20 minute oral presentation with questions will also be required. The review must be completed and presented by the end of semester 7. Semester 8: Pharmaceutical based project work (~ 170 hours) Following on from their literature reviews in semester 7, students will conduct a substantial body of experimental work over an 8 to 9 week period. They will have access to pilot plant and laboratory facilities for approximately 5 hours per day over that period. Each student will be assigned to a supervising lecturer who will take responsibility for overseeing the progress of the project. It is expected that many projects will be allied to ongoing research within the College allowing research students to have an input into the day-to-day supervision of the undergraduate projects. Students will be continuously assessed over this period to ensure that they: • apply a clear understanding of the principles and practice of their chosen pharmaceutical

techniques; • exercise an awareness of the principles and practice of validation and GLP in their

approach to their work; • demonstrate a comprehensive ability to interpret and analyse experimental data. All projects must be completed and presented before the end of Semester 8. Students will be expected to present their experimental findings in a style and format appropriate to that used in scientific journals. A 20 minute oral presentation with questions will also be demanded. Project Assessment: Semester 7: Literature Review: Review: 30% Project plan: 30% Oral presentation: 20% Continuous assessment: 20% Semester 8: Laboratory Work: Written report: 50% Oral presentation: 20% Continuous assessment: 30%

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MODULE TITLE: PROCESS CONTROL TECHNOLOGY SUBJECT NO. : PC42 PREREQUISITE SUBJECTS PH11, PH12, MA11 LEARNING OUTCOMES: Having successfully completed this module, the student will be able to: 1. Explain the construction, operation and maintenance of heat exchangers and evaporators and

their role in the manufacturing processes. 2. Operate, troubleshoot and maintain vacuum systems and pumps 3. Demonstrate an understanding of control technology. 4. Demonstrate a knowledge of the concepts and technology used in process control in the

pharmaceutical industry. SYLLABUS CONTENT Total hours: 24 Heat and thermodynamics. • Thermodynamic systems, states and process. First law of thermodynamics. Second law of thermo-

dynamics. Entropy. Heat engines and heat pumps. Refrigerators. Carnot cycles • Conduction through a composite wall. Conduction in cylindrical coordinates, Critical insulation

thickness. • Heat exchangers. Construction and operation. Applications of heat exchangers eg: process flow

sheets • Evaporators: Construction and operation of batch pan, rising/falling film tubular, forced circulation

and plate evaporators. Typical applications. • Overview of Pharmaceutical manufacturing technology. Vacuum technology • Gas properties: Kinetic theory. Velocity distribution, mean free path, particle flux, pressure. Gas

laws: Dalton’s law. Graham’s law. Thermal conductivity. Diffusion. Thermal transpiration. • Pressure Gauges: Thermal Mass flow and throughput. Calibration of pressure gauges. • Pumps: Rotary vane, rotary piston pumps. Turbomolecular pump. Diffusion pumps, backstreaming,

baffles and traps. Vacuum pump fluids. Cryogenic pumps. • Vacuum systems: Operation and Maintenance of diffusion pumped system and turbomolecular-

pumped systems. Demountable joints, Flanges and seals, metal gaskets. Vacuum system construction: materials. Lubrication techniques.

• Valves: Bellow sealed standard valves, Electro pneumatically-operated valves. Hydraulic valves, Procedures for leak detection. Leak detectors, residual gas analysers. Pressure drop method, bubble test, gas phase tracers, using He and a sniffer.

Control technology. • Models of physical systems. Time domain behaviour of mechanical, electrical, thermal and fluid

power systems. Transient behaviour of first and second order systems. Transfer function and block diagram representation.

• Behaviour of systems with feedback. Existence of steady state error. Sensitivity to parameter change. Speed of response.

• S-plane description of response, position of system poles and zeros. • System identification Ziegler – Nicholls, frequency response methods, bode plots. • Stability of linear feedback systems The problem of stability. Gain and phase margin • Practical controllers and compensators. PID compensation. Process controllers • Lead and lag compensation. Speed and position controllers.

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PRACTICAL COURSE: Total hours: 24 The majority of these practicals will take place in the pilot plant facility. • Thermal conductivity Experiments. • Investigation of plant efficiency. • Assembly and commissioning of vacuum system. Pumpdown Curves. • Leak detection in vacuum systems. • Examination of first and second order behaviour. • Motor speed control using PID control. • Investigation of on-line temperature control systems.

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MODULE TITLE: INDUSTRIAL STATISTICS II SUBJECT NO.: IS42 PREREQUISITE MODULES: IS22, ST12, MA11 LEARNING OUTCOMES: Having successfully completed this subject, the student will be able to: 1. Use troubleshooting techniques to identify potential problems and to implement improvements. 2. Understand the principles of clinical trials and medical statistics and conduct statistical analysis of various types of clinical studies. SYLLABUS CONTENT: 26 hours Troubleshooting techniques Pareto analysis. Histogram. Measles chart. Time series analysis. Contingency table analysis. Experimental design and ANOVA. Scatterplot. Implementing improvements: corrective and preventive action. Mistake proof devices and audits. Confirmatory runs, process capability re-assessment, continual improvement. Clinical Trials and Medical Statistics • Principles: theory, randomization, Intent-to-treat. Analysis: Primary outcome, secondary outcome,

adjusting for baseline covariates, drop-outs, multiple regression and logistic modelling. Statistics in validation. Comparative study design: prospective study, case-control study, observational study.

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Fourth Year Syllabi

Semesters Seven and Eight

Biopharmaceutical Science Subjects.

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SUBJECT TITLE: BIOPROCESS TECHNOLOGY SUBJECT NO. BP41 PREREQUISITE SUBJECTS MT21, AP31 Learning Outcomes: Having successfully completed this course the student will: 1. Be able to isolate, preserve and screen industrial microorganisms 2. Be able to select media for industrial fermentations 3. Be able to scale up a fermentation process to production scale 4. Have sufficient knowledge of fermenter design and control in order to be optimise a fermentation process. Syllabus Content: 39 hours of lectures Microbial Growth Kinetics Batch culture. Continuous culture. Fed batch systems.Multistage systems. Productivity measurement. Contamination control. Biomass production. Isolation Preservation and Improvement of Industrial Micro-organisms. Screening programmes for producers of therapeutic agents/antibiotics/pharmacologically active compounds/growth factors. Storage and preservation of industrial micro-organisms. The use of recombinant systems for the improvement of industrial micro-organisms. Media for Industrial Fermentations: Defined and complex media. Precursors, inhibitors and inducers. Antifoams. Medium optimisation. Sterilisation Methods: Batch and continuous sterilisation systems. Methods of sterilisation. Nutrient availability and sterilisation. Scale up of Bioprocesses: Lab scale. Pilot plant. Production scale. Scale up problems-Invalid statistical comparisons, Medium differences, Inoculum differences. True scale up problems. Fermenter Design: Aeration and agitation. Basic construction. Sampling. Impellers and baffles. Air sterilisation. Filters. Instrumentation and Control: Auotomation of cycle. Measurement of process variables. Temperature and pressure measurements. Stirring rates. Calibration. Production of Therapeutic Agents from Microbial Origin Anti-microbial peptide production. Anti-microbial properties. Screening, purification scale up and formulation

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SUBJECT TITLE: CELL TECHNOLOGY SUBJECT NUMBER: CT42 PRE-REQUISITE SUBJECT: PB23 LEARNING OUTCOMES Having successfully completed this course, the student will: 1. Be able to describe in detail the basic methods for the culture and maintenance of animal cell lines 2. Critically understand the design and importance of a cell bank 3. Be able to describe the principles and methods of cell line authentication from a technical and

quality control perspective 4. Have a demonstrable critical knowledge of animal cell culture media, their formulation and quality

control 5. Be able to describe different types of cell culture bioreactors, their principles of operation and

spheres of application 6. Understand the principles, applications and quality control of simple cell-based bioassay systems 7. Have demonstrated a technical competence in the handling and manipulation of animal cell cultures 8. Be able to illustrate their knowledge of cell technology through reference to appropriate case studies 9. Be able to follow cell culture procedures to produce a protein product. SYLLABUS 39 hours of lectures Basic principles of animal cell culture • Biosafety • Primary and established cell lines / Establishment and maintenance of a cell bank; freezing and

recovery of cell lines • Basic culture techniques - viability stains; subculture of cells - adherent and non-adherent cell lines;

growth curves; cell cloning techniques. Cell Culture Media • Components of cell growth media / Media preparation; microbiological QC of culture media • Serum - roles, sources, evaluation; serum-free media - components, evaluation Cell Line Characterisation • Assessment of contamination sources, effects, microbial (bacteria and fungi), mycoplasma

screening • Inter- and intra-species contamination; species verification - isoenzymes, DNA fingerprinting, • Biochemical characterisation - identification and characterization of immunological products,

human chromosome sorting and analysis, in situ hybridisation, marker enzymes • Validation of cell lines - FDA perspective Scale-up of Cell Cultures • Equipment and practical considerations / Media and nutrients • Types of culture process - monolayer cultures, suspension cultures, microcarrier systems, cell

bioreactors • Current trends and the impact of new technologies Plant Cell Technology • In vitro plant cell culture - propagation of plant cell cultures • Media for plant cell culture - Components / Preparation / QC • Trends - pharming Bioassays • Principles of bioassays / Design and application of bioassays • Calibration and validation of bioassays / International reference preparations & standards • End-point determinations Case Studies • Biopharmaceutical products produced from animal cell cultures - growth factors, recombinant

antibodies, vaccines

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MODULE TITLE: ADVANCED BIOPHARMACEUTICAL PROCESSING SUBJECT NO. AB41 PRE-REQUISITE SUBJECTS: MT2I, PT31, PA21 LEARNING OUTCOMES: Having successfully completed this module, the student will 1. Be able to optimise final stage processes for protein therapeutics 2. Be able to optimise lyophilisation processes to maximise product stability 3. Be able to formulate a final protein or peptide product.

Syllabus content: 39 hours Lyophilisation of proteins: • Engineering and Economic aspects of Freeze drying: Equipment, economics, Heat and Mass

Transfer and process control. Control of moisture: Secondary drying, changes in moisture on storage, stopper and moisture transfer; Validation / quality control issues. Stability of freeze-dried proteins: Mechanisms of stabilisation, general rules.

Protein Stability testing: • ICH guidelines and protein stability, Supplementary analytical techniques (Circular dichroism,

Differential scanning calorimetry, Malditof, Near IR etc); packaging and protein stability; Case studies on degradation of therapeutic proteins.

Protein Devices: • Regulatory aspects of devices, stability of immunoassay components; methods for determining

stability of assay components, antibody – antigen recognition, Biacore, case studies. Recent innovations in Protein formulation. • Difficulites in protein drug delivery; Protein drug formulation; biodegradable microparticles; solid

lipid nanoparticles; particle size analysis, transdermal, iontophoresis, Powderject technology Recent trends in Biopharmaceutical processing: • Case studies based on recent literature.

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MODULE TITLE : PHARMACEUTICAL BIOTECHNOLOGY II Semester Module PB42 Pre-requisite Subjects : PB31

LEARNING OUTCOMES:

Having successfully completed the course the student will be able to : 1. Optimise biotechnological production processes 2. Evaluate the contribution of various biotechnological processes towards product formation 3. Design and implement biotechnological processes within the biopharmaceutical industry

SYLLABUS CONTENT: Total: 39 hours Applications of biotechnology in the Biopharmaceutical industry • Expression systems for recombinant proteins in bacteria, yeast and mammalian cells • Considerations for production of pharmacologically active recombinant proteins and peptides • Specific growth parameters for optimisation of product formation and recovery • Optimisation of large-scale production of recombinant proteins • Biopharmaceutical products in the market place DNA micro-arrays in Biopharmaceuticals • Gene probe technology • CHIP technology • Pharmaceutical applications of micro-array technology Advanced PCR technology and applications in the Biopharmaceutical industry • Considerations for PCR optimisation • Diagnostic applications • Recent trends in PCR applications in Biopharmaceuticals Antibiotic development and large-scale production • Commercial production of antibiotics • Application of biotechnology in optimisation of antibiotic production Bioinformatics • Bioinformatics • Genomics • Proteomics • Developments in the human genome project and applications to the Biopharmaceutical industry • Data management Regulatory and legislative aspects of Genetically Manipulated Organisms • Legislative policies in Europe and the USA regarding the use of GMOs in the pharmaceutical

industry. • Environmental considerations and concerns regarding use of GMOs. • The definition, generation and protection of intellectual property. • Issue and protection of patents • Case studies Future developments in Pharmaceutical biotechnology • Emerging technologies • Case studies • Ethical considerations

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MODULE TITLE: PRACTICAL COURSE SUBJECT NO. PC41 CONTEXT: It is intended that this practical subject will be organised as a series of mini-projects with a duration of two or more weeks and that the majority of these practicals will take place within the biopharmaceutical pilot plant facility. A series of practicals will be organised in which the students will be encouraged to develop their ability to integrate the a number of disciplines in order to produce, purify and analyse biopharmaceutical products. The concept of team-work will be emphasised. In addition, the practicals will be carried out according to cGMP, where possible, and the need for both validation and statistical evaluation of results will be emphasized throughout. An underlying theme will also be the development of students oral and written presentation skills. A prescribed period of time will be set aside for students as a team to devise a suitable work strategy. This strategy will be discussed through the use of designated students acting as chairperson and speaker. The strategy will be critically evaluated by the students and amendments made where necessary. A specific period of time (10 to 12 hours per week) will be allocated to the implementation of the proposed strategy. Results will be collated and presented to the group as a whole. Designated students will again be required to act as chairperson and speaker. A written report will be submitted by each student. These reports will be evaluated on the basis of results obtained along with their understanding and the interpretation of the results. Other factors such as competency in the laboratory, time management and statistical evaluation, will also be assessed. Continuous assessment will be carried out through oral examination (viva voce) at the end of this module. It is intended that this form of assessment will test the students ability to think laterally in relation to available techniques when solving specific problems. The students understanding of practicals along with the concept of controls, process of validation and safety considerations will also be assessed. LEARNING OUTCOMES: Having completed this practical module the student will: 1. Be able to work individually or as part of a team; 2. Be able to integrate laboratory and processing techniques in order to solve prescribed

problems; 3. Be able to optimise and trouble shoot a process where necessary. 4. Have enhanced oral and written presentation skills; 5. Be able to critically evaluate analytical methods and use appropriate statistical

methods of evaluation; 6. Be able to execute efficient time management; 7. Be able to work within the boundaries of cGMP.

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SAMPLE PRACTICALS Production of an antibody from mammalian cells. This mini-project be carried out over 4 weeks and will involve: • Introduction to animal cell culture - cell viability and enumeration, subculture and cell preservation. • Bioassays - development of a cell cytotoxicity assay. • Determination of cell proliferation – MTT assay. • Culture of a hybridoma cell line and isolation of antibody protein. • Purification and analysis of the antibody • Lyophilisation of the purified antibody. • Comparison of lyophylisation with other drying methods, such as spray drying • Analysis of protein stability by DSC • Validation of an ELISA assay. Bioprocess Technology This mini-project will take place in the Biopharmaceutical pilot plant over 3 weeks and will involve: • Screening of bacterial culture collection for anti-microbial peptide production. • Lab scale production with selected strains. • Media sterilisation and optimisation. • Purification of proteins of interest. • Detailed studies of the anti-microbial properties. • Scale up of selected strains Down stream processing of a peptide therapeutic. This mini-project will take place both in the pilot plant and in the laboratory over a 3 week period and will include: • Production and purification and freeze drying of a peptide product • Evaluating a series of protein stabilising agents ensure protein stability. • Formulation of the peptide as a parenteral and enteral product. Consolidation of the theoretical component of the course in Biotechnology II will involve laboratory-based experimentation involving practicals such as • utilization of Bioinformatic programmes involving both genomics and proteomics, • optimization of selected PCR methods, • utilization of gene probes and reporter gene assays

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Fourth Year

Semesters Seven and Eight

Pharmaceutical Chemistry Option

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MODULE TITLE: ORGANIC CHEMISTRY (III) SUBJECT NO. OC41 PREREQUISITE SUBJECTS: OC2I & OC3I LEARNING OUTCOMES: Having successfully completed this module the student will: 1. Be able to choose the correct reagents for use in a range of organic syntheses & be able to

demonstrate the corresponding reaction mechanisms. 2. Draw the different stereochemical isomers for important heterocyclic & natural product compounds. 3. Be able to design and develop multi-step synthetic routes to heterocyclic and natural product

analogues. 4. Be able to carry out synthesis of a wide range of organic compounds. 5. Be able to use alkyl lithiums, metals, & other hygroscopic reagents in synthesis. 6. Be able to carry out stepwise synthesis, controlled additions at low temperature, vacuum

distillation,etc. 7. Be familiar with, and have a practical knowledge of the spectroscopic techniques used in

characterisation. 8. Be able to discuss organic reaction mechanisms as part of small group case study workshops. SYLLABUS CONTENT: Total Hours: 39 Heterocyclic Chemistry: 5- & 6-membered aromatic & aliphatic heterocyclic ring systems - reactivity, acidity/basicity, ring synthesis; indoles, quinolines, isoquinolines, azoles, triazoles, tetrazoles – reactivity & ring synthesis; applications in drug synthesis. Advanced Stereochemistry: conformational analysis – Nuclear Overhauser Technique, chiral shift reagents, Mosher’s acid, determination of enantiomeric excess, Optical Rotatory Dispersion/Octant Rule; pro-chirality; chirality in bicyclic systems, chiral centres other than carbon; allenes; biphenyls. Natural Product Chemistry: amino acids, peptides, alkaloids, terpenes, flavanoids,steroids with repsect to classification of biological samples & occurrence; synthesis & biosynthesis; applications to drug synthesis. Organometallic Reagents in Organic Synthesis: palladium, tin, phosphorous & sulfur reagents. PRACTICAL COURSE: 36 hours 1. Synthesis of dimedone & the determination of its tautomeric equilibrium constant using NMR. 2. Organic synthesis using n-butyl lithium reagent with spectroscopic analysis by IR and NMR. 3. Reduction of γ-butyrolactone with DIBAL & estimation by NMR of the relative proportions of

4-hydroxybutanal & its cyclic isomer in the production mixture. 4. Hydration of alkenes by hydroboration-oxidation:preparation of octan-1-ol from 1-octene. 5. Synthesis of Flavone and characterisation by IR and NMR spectroscopy. 6. Stereospecific preparation of trans-cyclohexane-1,2-diol via bromohydrin and epoxide

formation.

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MODULE TITLE: ORGANIC CHEMISTRY (IV)

SUBJECT NO. OC42 PREREQUISITE SUBJECTS: OC41, OC31 & OC21 LEARNING OUTCOMES: Having successfully completed this module, the student will: 1. Have the knowledge necessary to design syntheses of polyfunctional organic compounds. 2. Be able to understand and use the concepts and strategies in the design of Pharmaceuticals. 3. Apply the disconnection method to a target molecule & hence find the necessary synthons. 4. Know and be able to apply functional group transformations SYLLABUS CONTENT: Total Hours: 39 Retrosynthetic Analysis: • The Synthon method. • One group disconnections Simple alcohols; • Simple olefins; • Aryl ketones; • Control by blocking/protecting groups. Functional Group Interconversion: • Ring closure and opening reactions • Reagents for FGI. Principles of Design of Synthesis: • Two group and illogical disconnections. • Heterocyclic compounds. Synthesis of Pharmaceuticals: • Concepts and strategies in design of Pharmaceuticals. • Medicinal Chemistry case studies. • Combinatorial Chemistry • High-Throughput Synthesis

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MODULE TITLE: MANUFACTURING TECHNOLOGY III SUBJECT NO.: MT42

LEARNING OUTCOMES: Having successfully completed this module, the student will be able to: 1. Develop appropriate synthetic routes for the production of bulk pharmaceutical compounds. 2. Solve the problems of Scale-up. 3. Minimise waste in synthetic processes used in large scale production of chemicals. 4. Carry out Hazards Assessment as part of a Production team. 5. Develop appropriate analytical tests for purity determination and in-process monitoring. 6. Have a complete understanding of the physicochemical concepts of synthetic reactions and use as a tool to enhance yields and product selectivity. 7. Be able to carry out technology transfer to production. 8. Have a basic knowledge of relevant chemical engineering topics. 9. Be able to isolate, determine and minimise or eliminate impurities from appropriate reaction steps.

SYLLABUS CONTENT: Total Hours: 39 Process Research: Strategy; Lead compound selection; Patents; Case studies.

Process Development: Chemical Development - Chemical synthesis route selection; Chemical aspects of scale-up - solvents in chemical production; low temperature reactions; safe use of organometallic reagents; yield optimisation; robustness; polymorphism, case studies; Waste minimisation - the industrial approach, solvent recovery, catalysis - solid supports, phase transfer catalysts, polymer supports, optically active compounds; Hazards assessment procedures - COSHH, HAZOP, HAZAN. Analytical Development - Testing- raw materials, intermediates; final product; In-process monitoring; Physicochemical Concepts - Reaction profiles; Pre-equilibria; Competing reactions; Reactor configuration; Bulk and micromixing effects; Multiphase systems; Reaction modelling.

Technology Transfer to Manufacturing Plant: Chemical Engineering Topics - Flowsheets; Mass balances; Energy balances; Fluid flow; Reactor theory; Mass transfer theory; Stability testing; Technology transfer documentation.

Troubleshooting Impurities: Impurity isolation; Impurity identification - LC-MS, IR, UV, NMR, spectroscopic problem solving; Identification of reaction step in which impurities form; Minimisation /elimination from reaction step; Case studies.

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MODULE TITLE: UNIT PROCESSES II SUBJECT NO. : UP41 PREREQUISITE SUBJECTS LEARNING OUTCOMES: Having successfully completed this module, the student will: 1. Understand the theory of transition metal bonding and its relevance to synthesis in the

pharmaceutical industry 2. Be able to set up and complete standard transition metal catalysed reactions 3. Understand the chemistry and bonding of lanthanide complexes and their uses as catalysts 4. Know the principal industrially important catalytic reactions 5. Know the basic theory of crystallography and morphology and their relationship to reactivity in the

solid state and solution 6. Be able to use standard characterisation techniques in crystallography and particle size analysis SYLLABUS CONTENT: Total hours: 39 Industrial Catalysis Introduction, Theory of Bonding in transition metal compounds. General mechanisms of catalysis. Palladium catalysed carbon-carbon bond formation, organo-iron chemistry, transition metal promoted oxidations, titanocene and zirconocene η-2 π complexes. Chemistry of Lanthanide metals, bonding in lanthanide complexes, Applications of lanthanide complexes as catalysts. Powder Technology Fundamentals of Molecular Crystals: Structure of Crystalline Solids, Close packing principle, line group and plane group symmetries, space group symmetry, forces in molecular crystals, polymorphism. Reactivity in Solids: asymmetric synthesis in crystals, homogenous and heterogeneous thermal reactions, enantioselective reactions Crystal growth: crystal nucleation, epitaxy, growth mechanism, habit modification, Solid solution, solvent effects, optically anomalous crystals Physical properties: polar crystals, organic conductors, particle characterisation, microcapsules, micro-particles, pellets, overview of technical , techniques, and technical challenges PRACTICAL COURSE: Total hours: 24 1 Transition Metal-Carbon Bonds in Chemistry and Biology 2 Transition Metal Catalysis 3 Organotin Chemistry 4 Complexes of pi-bonding Ligands 5 Investigations into Lattice Energies 6 Particle Size analysis in the solid and liquid Phase 7 Nickel Catalysed Cross-Coupling of Alkylmagnesium with Haloarene