AnQual, your partner in drug development research · •Drug-drug and drug-excipient compatibility studies. ... liquid, and semisolids. ... your partner in drug development research

AnQual, your partner in drug development research


The University of AucklandThe University of Auckland is NZ’s pre-eminent research-led University. Established in 1883, it has grown into an international centre of learning and academic excellence and is NZ’s largest university. Teaching and research is conducted in eight faculties:

• Arts

• Business and Economics

• Education

• Engineering

• Law

• Medical and Health Sciences

• National Institute of Creative Arts and Industries

• Science

International ranking The University of Auckland is one of the world’s best universities; according to The Times Higher Education World University Rankings released in November 2007 it is placed 50th in the world. The University of Auckland has maintained its ranking in the top one percent of the world’s universities. The University of Auckland is the only university in New Zealand, and one of only four in Australasia, with membership of Universitas 21, an exclusive group of major research-intensive universities.

National ranking The 2006 Performance Based Research Fund (PBRF) assessment placed The University of Auckland first in the three funding components:

• Quality evaluation.

• Postgraduate research degree completions.

•External research income.

http://www.auckland.ac.nz/


The Faculty of Medical and Health Sciences was established in 1968 as The University of Auckland School of Medicine. The Faculty has developed a reputation for excellence in teaching and research.

Faculty mission

To improve the health of our local, national and global communities through excellence in teaching, research and service.

The Faculty of Medical and Health Sciences consist of five schools:

•Medical Sciences

•Medicine

•Nursing

•Pharmacy

•Population Health

These Schools consist of a number of Departments and Research Groups.

Faculty of Medical and Health Sciences

http://www.fmhs.auckland.ac.nz


The School of PharmacyThe University of Auckland’s School of Pharmacy is young but growing rapidly. Established in 2000, the School now has about 30 staff, 15 PhD students and a growing number of international research exchanges.

The School is an integral part of the Faculty of Medical and Health Sciences which has a well deserved international reputation for the quality of its teaching and research. As per Performance Based Research Funding (PBRF) evaluation carried out by TEC in 2003 and 2006, the School of Pharmacy is the top-ranking Pharmacy School in NZ.

The major research areas for the School include drug delivery, substance misuse, herbal medicines, and rational use of drugs. In addition to the Bachelor of Pharmacy degree, the School is actively involved with high quality post graduate programs and research. Our Postgraduate papers on Pharmaceutical assurance and regulatory affairs are highly popular.

Prof John Shaw

Head, School of Pharmacy

Director, AnQual Laboratories

ContactSchool of Pharmacy


The University of Auckland

Building 504, 85 Park Road

Grafton, Auckland

Telephone: + 64 9 923 6260

Facsimile: + 64 9 367 7192

http://www.fmhs.auckland.ac.nz/sop/


ANQUAL

http://www.fmhs.auckland.ac.nz/sop/anqual/about.aspx

AnQual Laboratories is part of the School of Pharmacy, established with a grant from the Tertiary Education Commission (TEC) and with significant support from The University of Auckland. AnQual is an initiative to establish teaching, research, and training capabilities and systems to support regulatory compliance with new and existing medicines.

AnQual is a registered GLP (Good Laboratory Practice) compliant analytical Laboratory, offering both GLP and non GLP studies.

AnQual is working in close collaboration with drug discovery research groups, pharmaceutical and biotechnological companies and academic institutions to determine the qualitative and quantitative composition of a pure drug or formulation. It also conducts bioanalysis, i.e. assays to determine drug concentrations in body fluids during pre-clinical toxicological and human clinical studies. These steps are essential in the development of marketable medicines and must be accomplished to the standards required by the regulatory authorities.


ANQUAL’s Vision, Mission and Objectives

VisionTo be recognised as a global leader in pharmaceutical analytical research, training and services

MissionTo provide excellent research, teaching and service capabilities and systems to support regulatory compliance with new and existing medicines

Objectives•Provide a GLP compliant, accredited pharmaceutical analytical facility for research and training in

Quality Assurance and Control (QA & QC)

• Provide the required support to pre-clinical and clinical development of potential new medicines and drug delivery systems.

• Supplement the teaching and practical training of undergraduate and postgraduate students.

• Provide an independent laboratory for analysis and quality control of human and veterinary pharmaceutical, biotechnological, and complementary medicines available in New Zealand and other countries.


Advisory CommitteeKey members of the Advisory Committee are:

Professor John ShawHead, School of Pharmacy

Director, AnQual Laboratories

Prof. Shaw is a familiar name in Pharmacy, known for his contribution and expertises in clinical pharmacy and therapeutics, primary health care, Health services research and health economics. He is a member of Pharmacy Council of NZ.

Professor Gil HardyChief Scientific Officer, AnQual Laboratories

Professor of Pharmaceutical Nutrition

Gil is a pharmaceutical scientist and nutritionist with over three decades of experience with novel delivery systems and GLP/GMP/GDP. He is a European ‘Qualified Person’ and an active member of many professional societies. He registered the first biological product in UK, has written several ‘Expert Reports’ for European drug registrations and and has successfully submitted over 50 product registration dossiers to the MHRA. Gil provides a consulting service for safety assessment and pharmacoviigilance on biologicals and chemicals to the biotechnology, pharmaceutical, food and cosmetics industries. He also lectures on parenteral formulation, GMP, Quality Assurance and other pharmaceutical and regulatory issues.

Professor Bill DennyDirector, Auckland Cancer Society Research Centre;

Co-Investigator, AnQual Laboratories

Bill is well known for his contribution to cancer research in the areas of new drug discovery. He is the co-founding scientist of Proacta Therapeutics and Co-PI in the centre for Molecular Biosciences, The University of Auckland.

Ms Asma OthmanQuality Systems Manager, AnQual Laboratories

Asma is responsible for quality assurance of projects carried out at AnQual. Her expertise is in analysis, method development and validation, quality assurance and control, and training on GLP/GMP.


What is Good Laboratory Practice (GLP)?Good Laboratory Practice (GLP) is a part of GXP’s which also includes Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP).

GLP is a quality system dealing with non-clinical analytical and safety studies on test items such as, pharmaceutical and cosmetic products, complementary and alternative medicines, veterinary and biotechnological products. In a typical pharmaceutical manufacturing environment a GLP laboratory is an independent but integral part of GMP.

Benefits of GLPReliability, integrity, traceability and reproducibility of the data generated from analysis of raw materials and formulations intended for human or veterinary use is critical to ensure their safety and efficacy.

Compliance to GLP ensures use of systems and procedures to facilitate this requirement in a controlled environment.

GLP compliant status means that all analytical studies are carried out by trained staff, using calibrated instruments, validated methods, with the highest attention to detail, and following documents acceptable to regulatory authorities around the world.

•Enhances credibility of data and reporting

•Promotes acceptance of data internationally

•Reduces technical barriers to trade

•Provides improved and most cost effective facility

•Better traceability and reproducibility of data

AnQual is a GLP compliant analytical facility, registered with International Accreditation New Zealand (IANZ) offering both GLP and non GLP studies.



Our services

Preformulation •Physico-chemical characterisation of drugs.

• Drug solubility assessment and improvement.

•Stability assessment and improvement.

• Solid state characterisation, polymorphism.

• Drug-drug and drug-excipient compatibility studies.

• Data for new drug application (IND and NDA).

Analysis and quality control • Preclinical and clinical analysis of drugs, metabolites and excipients in the pure

form, formulations, and biological samples.

• Analytical Method Development and Validation.

• Stability indicating method development and Testing (ICH).

• Pharmacopoeial testing of solid, liquid, and semisolids.

• Standardisation of complementary and alternatives medicines.

Formulation• Conventional and novel drug delivery systems and technologies including solids,

semisolids and liquids.

• Bioadhesive preparations.

• Taste masking.

• Complementary medicines

• Vaginal and rectal microbicides and anti-infectives.

•Anti-cancer drug delivery.

• Extemporaneous compounding.

• Manufacturing process optimisation.

• Formulation for preclinical and clinical studies.

•Patentable non-infringing platform technologies.

Consultancy• Independent consultancy services on product development, quality control,

preparation for GLP/GMP and regulatory submissions.

• External auditing.

• Intellectual property issues.


Ongoing and completed projects

Preformulation•Preformulation studies with selected anticancer drugs.

•Drug excipient compatibility study of an anti-HIV drug.

•Stability evaluation of a protein lead molecule.

•Solubility improvement using nanotechnolgy.

Analysis and quality control•Bioanalytical method development and validation for pharmacokinetics studies.

•Method development and validation for a Drug and it’s metabolites in plasma for clinical studies.

•Method development, validation and analysis of antibiotics in fish tissue samples.

•Photostability studies as per (ICH) guidelines.

•Stability of extemporaneously compounded hospital formulations.

•Fingerprinting and stability evaluation of a herbal formulation.

Formulation•Development of a novel bioadhesive vaginal microbicide formulation.

•Taste masking of a drug for inclusion in fish feed.

•Process optimization for preparation of a cream formulation and its stability evaluation.

•Development and optimisation of a lotion made from natural ingredients.

•Novel nanotechnology based anticancer drug delivery systems.

Consultancy•Expert comments on a formulation patent infringement case.

•Help with writing of SOPs for a new laboratory.

•Expert opinion on registration dossiers.


Standardisation of complementary medicines and dietary supplementsQuality control of herbal active ingredients and formulations can be very challenging because of a numbers of reasons such as multiple active ingredients, lack of analytical methods, and inherent variations in the products.

AnQual can work with you on solving the mystery of herbal drug standardisation in the following areas;

• Development of new analytical method(s) for active ingredient(s) and formulation by High Performance Thin Layer Chromatography (HPTLC), HPLC, and LC-MS.

• Stability evaluation.

• Finger printing and assay of herbal extracts/products based on chemical markers.

• Isolation, identification and characterisation of marker constituents from extracts.

• Tests for

• Foreign matter.

• Other tests, e.g. total ash, extractable matter, swelling index.

• Loss on drying.

• Pesticide residues.

• Aflatoxins.

• Compilation of relevant sections of registration dossiers.

• Compliance with regulatory agency and pharmacopeial requirements.


Analytical Pharmacopoeial testing Formulation

LC-MS Disintegration tester Tablet machine

HPLC with the following detectors:

Photodiode array (PDA)

Evaporative light scattering detector (ELSD)

Fluorescence

Ultraviolet (UV) and

Refractive index

On/off-line dissolution tester (with autosampler, fraction collector and auto dilution)

Flow through cell

(Transdermal research)

UFLC Friability tester Viscometers

GPC Hardness tester Hot stage microscope

HPTLC Balances Moisture analyser

GC with

Flame ionisation (FID) and

Electron capture (ECD) detectors

High pressure homogeniser and ultrasonicator

Fourier transform infrared (FTIR)Particle size analyser Zetameter

pH meter with various electrodes Cytotoxic cabinet class II

Refrigerated centrifuge Texture analyser

Polarimeter Stability champers including photostability

UV spectrophotometer

Freeze dryer

ELISA plate reader

Equipment

In addition to the above list we have access to a large number of equipment available in other departments of the University such as:

•DSC•XRD•TGA•Imaging Systems including confocal, SEM, TEM etc.


Training AnQual offers specialised training programmes such as HPLC, Laboratory Skills and GLP/GMP. Tailor made training programmes can be arranged to suit special requirements.

Examples of training courses previously offered at AnQual

“One to One” training on HPLCAnQual offers one to one training to individuals on HPLC. The training covers both practical and theory aspects of HPLC. Students and individuals wanting to up skill would benefit from this course.A certificate will be presented to applicants on completion of this course.

Refresher course on HPLCThis course attracted 36 participants from academia and industry. It was driven by a pool of experienced and expert speakers; scientists and analysts from pharmaceutical companies, equipment engineers from different HPLC manufacturers, research staff and peer academicians from the other faculties within the University.

Basic analytical and GLP skillsThere were 16 participants from Healtheries NZ Limited.

The content of the course was designed specifically for Healtheries and covered both theory and practical sessions.

A combined course/conference on stability with International Society for Pharmaceutical Engineering (ISPE) is currently being planned.

We are working on developing online training programmes. AnQual can also support short term research projects summer studentships and honours.

Basic analytical and GLP skills June 2007


Postgraduate study Students interested in preformulation, formulation, and quality research can enrol in Postgraduate Programmes in Pharmaceutical Science, which include the following:

Certificates of ProficiencyStudents may take single courses offered by the School of Pharmacy as part of their personal professional development plan and will receive a Certificate of Proficiency in relation to those courses.

Postgraduate Certificate in Health SciencesThis programme requires completion of courses totalling 60 points selected from PHARMACY 750, 751, 752 & 753.

Postgraduate Diploma in Health SciencesStudents holding the PGCert HSci can proceed to the Diploma by completing a further set of courses to a total of 120 points.

Master of Health Science

Students holding the PGDipHSc may proceed to the Master of Health Science by completion of a 120 point research thesis.

Available courses PHARMACY 750 Pharmaceutical Formulation (30points)

PHARMACY 751 Pharmaceutical Techniques (30 points)

PHARMACY 752 Pharmaceutical Quality Assurance (15 points)

PHARMACY 753 Regulatory Affairs (15 points)

PHARMACY 754 Research Proposal (15 points)

PHARMACY 761 Special Studies (15 points)

Student supervisionAnQual can work with potential sponsors and collaborators on mutually beneficial and acceptable arrangement such as joint supervision of Masters or PhD students.

AnQual offers opportunities for research-based projects and provides the necessary facilities and supervision. For students from industry, we encourage them to work on projects related to their employment, in collaboration with their employer.

Ph.D. in PharmacyThe Doctorate degree requires students to work on a novel research project over 3.5-4.0 years.

We invite you to make the best use of an academic and commercial research driven analytical facility, within the Faculty and University.

Contact Gil Hardy ([email protected]) for further information on any of the above programmes.


How we handle projectsAnQual manages confidentiality agreements, intellectual property, finances and reports through Auckland UniServices Ltd, the commercialisation arm of The University of Auckland.

AnQual is very keen in dissemination of research results in agreement with sponsors and collaborators, i.e. publications and presentations.

We can provide or contribute to:

•Writing the relevant portion of grant application as collaborator or sub contract laboratory.

•Providing the budget, CVs etc, which is likely to strengthen the funding application because of the Laboratories’ status?

•Handling the research involved, if the grant is funded.


UniServices The majority of AnQual commercial projects are managed by UniServices.

Auckland UniServices Limited is a limited liability company wholly owned by The University of Auckland. It provides research, consulting and technology transfer services within New Zealand and internationally. Research is undertaken utilising the contract, financial and project management skills of UniServices and the knowledge and expertise of the academic staff of the University. UniServices is also able to access research networks both within and outside the University to further inform the work being undertaken and, when required, is able to collaborate effectively with researchers at other Universities and with other organisations.

Alongside the infrastructural support given provided by UniServices, project teams have full access to all facilities and infrastructure available at The University of Auckland. This includes library and communication facilities, access to websites and IT services. The project team will be lodged within the University campus, thus giving them access to a wide range of other services and networks.

UniServices employs 45 core staff of which 14 are responsible for the management of projects. A further 507 contract and permanent staff are attached to our businesses on short to long-term projects. UniServices’ current financial revenue of $70 million per annum makes it a financially viable and stable organisation. At the same time, it is small enough to be flexible and non-bureaucratic, so as to provide project teams with:

•Personalised support and project management.

•Financial management structures and expertise.

•Employment of project staff/subcontracting.

•Commitment to delivery of high quality contract outputs.

Contacts Andrew Palairet

Phone: +64 9 923 8245

Mobile: +64 21 859 663

email: [email protected]

http://www.uniservices.co.nz


Our team

Left to right: S. Behera, A. Othman, G. Hardy, M. Sharma, A. Collocott


Professor Gil Hardy Chief Scientific Officer

Phone: +64 9 923 8402

Email [email protected]

Ms Asma Othman Quality Systems Manager

Phone +64 9 923 6228

Email a.othman@auckland

Mr Sairam BeheraSenior Analyst

Phone: +64 9 923 6284


Mrs Amanda CollocottAdministration Manager

Phone: +64 9 923 6532


Contact us

AddressAnQual Laboratories

School of Pharmacy


The University of Auckland

Private Bag 92019

Auckland 1142

New Zealand

Building 503, Room B02

85 Park Road, Grafton

Phone: +64 9 923 6228

Fax: +64 9 373 7524


http://www.fmhs.auckland.ac.nz/sop/anqual/about.aspx


Enquiry form Please take a few minute to complete this form as it will assist us in dealing with your enquiry more efficiently. Please provide us with as much information as possible, add further pages if necessary. If

questions are irrelevant, please write N/A.

Your details

Organisation Name

Organisation Address

Key contact (s)

Name and Designation

Phone number (Business)

Phone number (Mobile)

Email

Name and Designation

Phone number (Business)

Phone number (Mobile)

Email

Background of the project

Page 1 of 2


Type of project (tick more than one if applicable)

Analysisq Stability q Method Development q Method Validation

q Analysis of samples

q Active Formulations

q Biological Samples - Urine, Serum

q Complementary Medicines

q Others _____________________________

Physical chemical testingq Dissolution qRelease Studies q Pharmacopoeial Testing qOther

q Formulation Development

q Advisory / Training / Audits / Research supervision

Method of AnalysisDo you have a specific method of analysis that you would like us to follow? q Yes q NoIf you answered No to the above question, do you have reference papers/pharmacopoeial/regulatory guideline that you would like us to use? q Yes q No

Would you be able to provide us with reference material? q Yes q No

Does this project require Good Laboratory Practice (GLP) compliance? q Yes q No

Are you open to publication of new research outcome from the project q Yes q No

Budget and fundingYour estimation of costs involved _______________$NZ

Do you need assistance with grant writing? q Yes qNo

If yes provide further information_______________________________________________________

_______________________________________________________________________________

_______________________________________________________________________________

Enquiry form

Page 2 of 2

Please return form by fax +64 9 373 7524 or email [email protected] or return by post to AnQual Laboratories, School of Pharmacy, The University of Auckland, Private Bag 92019, Auckland 1142, New Zealand


Sponsors and CollaboratorsActivatas, NZ

AFT Pharmaceuticals Ltd, NZ

Ancare Laboratories, NZ

Argenta, NZ

Auckland Hospital, NZ

Baxter Healthcare, NZ

Bomac Laboratories Limited, NZ

Clinical Trials Research Unit (CTRU), The University of Auckland, NZ

Contraception Research and Development Program (CONRAD), USA

Douglas Pharmaceuticals, NZ

Ferrar International, Spain

GlycoSyn Industrial Research Limited, NZ

Healtheries of New Zealand Ltd, NZ

International Partnership for Microbicides (IPM), USA

LCT technologies, NZ

Meracol Corporation Limited, NZ

National Institute of Water & Atmospheric Research (NIWA), NZ

New Zealand Pharmacy Education and Research Foundation (NZPERF), NZ

Proacta Therapeutics Limited and Auckland Cancer Society Research Centre (ACSRC), NZ

Sharp Concepts, NZ

Southern Cross Biotechnologies NZ Ltd, NZ

TSI NZ Limited, NZ

Vital Foods, NZ

Documents

AnQual, your partner in drug development research · •Drug-drug and drug-excipient compatibility studies. ... liquid, and semisolids. ... your partner in drug development research