International Pharmaceutical Academy

International Pharmaceutical Academy: "

Validation of Biological Assays

Strategies for Effective Method Design and Validation for Producers of Biological Products

With participation from

A Two-Day Interactive Course with Workshops and Discussions on:

• What are bioassays? - definition of terminology used
• Why are they required? - scientific and regulatory requirements
• Examples of bioassays with descriptions of analytical instrumentation requirements
• Reference standards for bioassays
• Strategies for minimising variability
• Design and validation of bioassays
• Setting specifications for bioassays
• Use of bioassays in pre-clinical/clinical sample analysis
• Quality Assurance viewpoint on Bioassays
• Alternatives to proliferation assays (new technology, signaling pathway assays, etc.).
• Planning for Assay Development
• What is a Biological Assay Versus a Chemical Assay?
• Use of Compendial Procedures and Those from the Literature
• Considerations During the Assay Development Process
• Test Method SOPs
• Timing and Verification of Training
• Management of Assay Development and Validation
• Applying Process Controls
• Determining Numbers of Replicates
• Defining Accuracy and Precision
• Determining Range, Linearity, Specificity & Sensitivity
• Ruggedness and Robustness
• Minimizing Analyst and Instrument Variability
• Parallel Line Bioassays
• Determination of Titer and Other Microbial Tests
• Preparing a basic control chart

Distinguished Course Leader

Dr. Steven S. Kuwahara

Principal Consultant

GXP BioTechnology LLC

Originally from Hawaii, Dr. Kuwahara holds degrees in Biochemistry from Cornell and Wisconsin. After starting as an Assistant Professor of Chemistry, he began his industrial career in the Division of Biologic Products at the Michigan Department of Public Health (now BioPort Corp.), where he became the head of Quality Control. Here he developed expertise in the testing of blood derivatives, viral and bacterial vaccines. He moved to the Hyland division of Baxter Biotech where he was in charge of assay development and quality control. He later became responsible for quality systems for a biological device. After a short period with a contract testing laboratory and another blood fractionator, he became the director of quality control with a gene and cell therapy company. In recent years he has worked as the director of assay validations for a large contract testing laboratory and as a GMP consultant to a start-up cell therapy company. His last position was Director of Quality Control and Assay Development with Titan Pharmaceuticals. He is currently the Managing Director of his company, GXP BioTehnology LLC.

Dr. Kuwahara is an experienced analytical biochemist who has applied his academic knowledge to the areas of clinical chemistry and quality control in the pharmaceutical industry. He work has also dealt with all aspects of GMP and GLP in relation to biopharmaceuticals.

Dr. Kuwahara has written several papers and book chapters and serves on the editorial advisory boards of BioPharm, BioQuality, and the Journal of GXP Compliance. He has held certifications as a CQA, CQT, and CQE from the American Society of Quality and was certified (RAC) by the Regulatory Affairs Professionals Society.

Ms. Helen MacDonald-Piquard, M.Sc.

Senior Biologist/Evaluator, BGTD

Health Canada

Helen MacDonald-Piquard, M.Sc., is a Senior Biologist / Evaluator (Chemistry and Manufacturing), with the Pandemic Influenza Division, Centre for Biologics Evaluation (CBE), Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Health Canada. She has more than 9 years of experience as a biopharmarmaceutical and therapeutic product regulatory officer, specializing in hormone and enzyme, and vaccine product CTA, NDS, S/NDS, and NC review and lot release.

She has acted as Science Advisory to Health Canada’s Environmental Assessment Regulations Initiative, directing policy analysis and review requirements for biochemicals and biopolymers, and provided scientific, regulatory and management advice in the development of appropriate regulations, external contracts and stakeholder consultations, on various files, such as the Biosafety Protocol, the Plant/Animal Derived Biopharma Working Group, and the Good Laboratory Practices (GLP) Regulations Initiative.

She also has former experience as a Health & Life Sciences Specialist, and Biophysics Research Laboratory Manager, and ISO 9001 Quality Assurance Program Coordinator, for industrial and medical biochemistry research laboratories. Her interests have also included biotechnology industry oversight and editorial responsibilities for the Canadian Biotechnology Advisory Commitee (CBAC), Biotech Canada, and other industry publications.

Tina S. Morris, Ph.D

Director, Biologics and Biotechnology

Department of Standards Development

U.S. Pharmacopeia

Dr. Tina Morris is Director, Biologics and Biotechnology in the Department of Standards Development at USP, which she joined in 2003. She coordinates standard-setting activities in the division related to biologics and biotechnology and manages the scientific liaisons responsible for the relevant Expert Committees.

Before joining USP, Dr. Morris' industrial experience includes major biotech companies in the areas of analytical development, especially mass spectrometry, and recombinant protein characterization. Dr. Morris is the holder of several United States patents in the areas of virology and mass spectrometry assay development. She is the author of more than 20 publications in peer-reviewed journals and a frequent invited speaker at national and international scientific conferences.

Before working in industry, Dr. Morris was a Young Investigator Award Fellow for the German Cancer Research Center at the National Institute of Allergy and Infectious Diseases in Bethesda, working on the Virology of Hepatitis A with Dr. Robert H. Purcell. Dr. Morris earned her Ph.D. degree in molecular virology at the Medical University of Lübeck, Germany and her MS and BA degrees in biology at the University of Oldenburg, Germany.

Dr. Gwendolyn Wise-Blackman

Senior Manager, Cellular Technologies

Cardinal Health

Dr. Wise-Blackman is currently Senior Manager, Cellular Technologies, at the Cardinal Health RTP-Bio site. Dr. Wise-Blackman leads a team that successfully develops, optimizes, validates, and performs cell-based assays for lot release and stability projects in a GxP environment She was the co-recipient of both the Customer Focus Award for 3rd Quarter FY2004 and the Presidents Award for FY2004. Her expertise is GMP bioassays to support release and stability testing of biotechnology products, GLP ELISA assay development and validation, Cell Based Screens, and Receptor Binding Assays. Dr. Wise-Blackman was previously employed at Dupont Pharmaceuticals for nine years, working in the cardiovascular pharmacology and high throughput screening departments. She received her Ph.D. in Pharmacology from the University of Virginia, Charlottesville, VA and her Bachelor of Science in Biology from the Massachusetts Institute of Technology, Cambridge, MA.

Program Agenda

Day 1	Monday September 10th, 2007
8:00 AM - 8:30 AM	Registration and Continental Breakfast
8:30 AM - 10:15 AM	Assay Development - Early Stages Determining what are you measuring Establishing reasons for a test Frequency of measurement Level of sensitivity Do you really need a special instrument? Selecting a method and a type of assay
10:15 AM - 10:30 AM	Mid-Morning Refreshment Break
10:30 AM - 12:00 AM	Assay Controls Orthogonal methods Standards versus control samples Preparation of standards and controls Establishment of standards and controls Test Method SOPs Training and verification of the training
12:00 PM - 1:15 PM	Luncheon
1:15 PM - 2:45 PM	Assay Development (Late Stages) Prevalidation studies Tests requiring animals Special microbiological tests Parallel line bioassays Tests not considered in the guidances
2:45 PM - 3:00 PM	Mid-Afternoon Refreshment
3:00 PM – 4:00 PM	Applying Process Controls to Bioassays Design Defining Assay Limits Design of assays to determine limits Define suitable process control limits Analyze data sets to incorporate process defined controls that signal approaching limits Applying Process Controls Selecting suitable process controls Setting appropriate limits Setting activation and alarm points Case Study Discussion
4:00 PM - 5:15 PM	Workshop A - Interactive Group Activity Let's develop an assay. Class will be divided into groups who will be assigned tests to develop Groups will discuss development of the tests and any special considerations.
5:15 PM - 5:30 PM	Questions & Answers
5:30 PM	Conclusion of Day One
Day 2	Tuesday September 11th, 2007
8:00 AM - 8:30 AM	Continental Breakfast
8:30 AM - 9:30AM 9:30 AM - 10:30AM	USP Update: Current efforts on Bioassay General Chapters Bioassays: Challenges and Opportunities Use and limitations of bioassays Potency, equivalence, and validation: statistical approaches in the compendium Parrallelism in current <111> Replacing bioassays: challenges and points to consider Assay Validation Reference standards for bioassays What is required by the guidance documents Defining accuracy Defining the different types of precision Determining the number of replicates to use Preparing for assay validation and transfer
10:30 AM - 10:45 AM	Mid-Morning Refreshment Break
10:45 AM - 12:15 PM	Test Parameters and Validation Challenges for Bioassays Optimization studies Defining range and linearity for validation parameters Obtaining sufficient data for ruggedness and robustness Performing appropriate statistical analysis on the data Defining specificity and sensitivity Minimizing Analyst and Instrument Variability Parallelism Demonstrating that a test is as good as or better than the preceeding
1215 PM - 1:15 PM	Luncheon
1:15 PM - 2:00 PM	Biological Standards - Vaccines: USP Approaches New relevant General Chapter developments and revision efforts
2:00 PM - 2:30 PM	Health Canada Presentation: Biological Assays - A Regulatory Perspective
2:30 PM - 3:15 PM	Workshop B - Interactive Group Activity Setting up a Shewhart (Control) chart and monitoring an assay Participants will walk through the set up of a basic control chart
3:15 PM - 3:30 PM	Questions and Answers
3:30 PM	Conclusion of Program

Who should attend?

This two day course, case studies and workshop program is directed toward Managers, Supervisors, Analysts, and Associates in the Biologics, Biopharmaceutical, Biotechnology, and allied industries with daily responsibilities in the following areas:

• Quality Assurance
• Quality Control
• Quality System Auditors
• Regulatory Affairs
• Analytical Development
• R&D
• Project Management
• Statisticians
• Validation
• Compliance
• Manufacturing and Process Development

Registration Information:

Registration Fee: $825.00 + GST (6%)

- Multiple Registrations:
Send five attendees and the sixth is FREE!

Online Registration Payment Information Hotel Information

Registration Fee Includes:

Presentation Materials, Luncheon and Refreshments

Cancellation/Substitutions Policy:

Registration in a program may be transferred to a member of the same organization at any time. All cancellations are subject to a $200.00 (+ 6%GST) processing fee. A request for cancellation must be received in writing, by mail or fax, more than ten business days prior to the program event, in order to receive credit towards attending another IPA Program. Cancellations received less than ten business days prior to the program event are not accepted.

Certificate of Attendance:

All participants will receive a certificate of attendance upon completion of the course

For registration or any further information, please contact us at:

Tel: (416) 410-7402
Fax: (416) 491-5810 "