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Biopharmaceutical DivisionBiopharmaceutical DivisionOverviewOverview
Life Scientific Ltd.Life Scientific Ltd.
Contract Development Organisation that has assisted, since its foundation in 1995, the
development, validation and regulatory requirements of the following industries:
Biopharmaceutical
Pharmaceutical
Plant Protection/Agri
About UsAbout Us
• Why entrust Life Scientific with key study needs: Privately owned, organically grown customer-focused CRO ~15 years experience in outsourcing industry >75% of business is from either referrals or return clients
• GLP and GMP certified Laboratory Facilities: – Bio: NovaUCD, Belfield Innovation Park, UCD– Agri/Pharma: Blackrock, Co. Dublin
• Staff: Backgrounds from across drug development industry including:– Biopharmaceutical (Immunotherapy) – Diagnostics (Biomarkers, Infectious Disease)– Other CROs (Bioanalytical) – Pharmaceutical
Biopharmaceutical DivisionBiopharmaceutical Division
Core expertise: development, validation and utilisation of proteomic, immuno and cell-based methodologies for the analysis of:
• Biopharmaceuticals
• Biomarkers
Biopharmaceutical Biopharmaceutical DivisionDivision
BioPharm ServicesBioPharm Services
Primary services Method Development Method Validation Analysis
Safety Efficacy Evaluation
(Pre)Clinical PKImmunogenicity NeutralisationBiomarker
QC PurityPotencyStabilityIdentity
GLP GMP
Preclinical
Phase
I, II, III
Phase IV
Registration
BioPharm ServicesBioPharm Services
Primary services Method Development Method Validation Analysis
Safety Efficacy Evaluation
(Pre)Clinical PKImmunogenicity NeutralisationBiomarker
QC PurityPotencyStabilityIdentity
GLP GMP
Preclinical
Phase
I, II, III
Phase IV
Registration
We are experts in the development and validation of customised immuno, proteomic and cell-based methods
for evaluation of:
Biomarkers
Biopharmaceuticals
Biopharmaceutical related factors
(anti-drug antibodies, neutralising antibodies, process and product related impurities etc.)
BioPharm ServicesBioPharm Services
Primary services Method Development Method Validation Analysis
Safety Efficacy Evaluation
(Pre)Clinical PKImmunogenicity NeutralisationBiomarker
QC PurityPotencyStabilityIdentity
GLP GMP
Preclinical
Phase
I, II, III
Phase IV
Registration
Our customised immunoassay methods will ensure accurate, precise and sensitive detection of:
• Drug
• Anti-Drug Antibodies (IgG, IgM, IgA etc.)
• Biomarkers of efficacy/toxicity/safety/response
BioPharm ServicesBioPharm Services
Primary services Method Development Method Validation Analysis
Safety Efficacy Evaluation
(Pre)Clinical PKImmunogenicity NeutralisationBiomarker
QC PurityPotencyStabilityIdentity
GLP GMP
Preclinical
Phase
I, II, III
Phase IV
Registration
Life Scientific can assist your biomarker and diagnostic requirements, be they focused on analysis of probable or
known valid biomarkers, surrogate endpoints, fit-for-purpose analyses, analytical validation or clinical validation.
BioPharm ServicesBioPharm Services
Primary services Method Development Method Validation Analysis
Safety Efficacy Evaluation
(Pre)Clinical PKImmunogenicity NeutralisationBiomarker
QC PurityPotencyStabilityIdentity
GLP GMP
Preclinical
Phase
I, II, III
Phase IV
Registration
Services include• Method and Product Design, Development and Validation• Immunoassay Probe Design for maximisation of
- Clinical sensitivity and specificity
- Translational/bridging/cross species capability• Analytical and Clinical Validation• Project Management• On site/multi-site validation for intra-and inter-laboratory reproducibility
BioPharm ServicesBioPharm Services
Primary services Method Development Method Validation Analysis
Safety Efficacy Evaluation
(Pre)Clinical PKImmunogenicity NeutralisationBiomarker
QC PurityPotencyStabilityIdentity
GLP GMP
Preclinical
Phase
I, II, III
Phase IV
Registration
Read Biomarkers in Drug Development in the February 2007 issue of Pharma Magazine
http://www.nxtbook.com/dal/viamedia/pharmadigitalfeb2007/index.php
BioPharm ServicesBioPharm Services
Primary services Method Development Method Validation Analysis
Safety Efficacy Evaluation
(Pre)Clinical PKImmunogenicity NeutralisationBiomarker
QC PurityPotencyStabilityIdentity
GLP GMP
Preclinical
Phase
I, II, III
Phase IV
Registration
Life Scientific can assist your QC processes via assessment of:
• Potency
• Stability
• Comparability
• Identity: peptide mapping, sequencing etc.
• Product related impurities: aggregates, degradents
• Process-related impurities: LPS, Host Cell proteins, Host Cell DNA
Typical technologies used: PAGE, HPLC, SEC, IEX, IEF, ELISA, CELL-BASED, HYBRIDISATION, etc.
BioPharm ServicesBioPharm Services
Primary services Method Development Method Validation Analysis
Safety Efficacy Evaluation
(Pre)Clinical PKImmunogenicity NeutralisationBiomarker
QC PurityPotencyStabilityIdentity
GLP GMP
Preclinical
Phase
I, II, III
Phase IV
Registration
Cell-based assays
Life Scientific possess an expertise in the development and validation of in vitro assays for evaluation of biological effects. This service may facilitate Potency and Neutralisation investigations. Typical formats performed include:
1. Proliferation: quantification of growth stimulation
2. Cytotoxicity: quantification of growth inhibition
3. Differentiation: investigation of cellular marker profiles
BioPharm ServicesBioPharm Services
Primary services Method Development Method Validation Analysis
Safety Efficacy Evaluation
(Pre)Clinical PKImmunogenicity NeutralisationBiomarker
QC PurityPotencyStabilityIdentity
GLP GMP
Preclinical
Phase
I, II, III
Phase IV
Registration
Life Scientific provides regulatory affairs expertise on tap to help solve your registration and licensing issues. We offer a complete range
of services, throughout Europe, from strategic consulting to maintenance support.
Partnering with Life Scientific Partnering with Life Scientific
• Time efficient method development and validationexpertise
• Additional capacity for time sensitive projects
• Skill sets that compliment current in house capabilities
• Additional assurance of reaching in house milestones
• An Analytics and Regulatory solution to those who wish to operate a (semi) virtual model
Quality SystemsQuality Systems
• Our laboratories were the first within Ireland to obtain GLP certification
• Our Quality Systems are based on Standard Operating Procedures
• We perform Routine self-inspection and welcome client facility inspections
Science, the method of attaining Science, the method of attaining
knowledge by verifiable meansknowledge by verifiable means
ContactsContacts
Biopharmaceutical Division
NovaUCD, Belfield Innovation Park,UCD, Dublin 4, Ireland
Tel: +353 1 716 3511
Andy [email protected]