Institute for International Research

Course Description

Bioassays are necessary components of the biopharmaceutical development process as functional potency assays during release, stability and formulation studies. The appropriate use of non-analytical techniques is also critical during PK/PD evaluation and in the measurement of systemic responses to drugs (i.e., immunogenicity). Furthermore, immunological and enzymatic methods are widely used in the detection of biological impurities due to their increased sensitivity and specificity over analytical methods (i.e., HPLC). The complexity of the materials and procedures involved in these technologies, however, result in significantly increased variability as compared to analytical methods.

The lecture portion of this course outlines sensible approaches to develop reproducible bioassays using live systems and/or biologically derived reagents. These approaches are supplemented by guidelines to meet regulatory requirements according to their application. In addition, a workshop on writing validation protocols provides hands-on experience to cover these pivotal documents. You will also hear case studies that add relevance to the lecture materials and provide a launch point for class discussion.

Complete Course Agenda

Introduction to Potency Bioassays

• GMP and GLP Overview
• Differences between GMP and GLP Expectations

Development:

• Early and Late Stage Development
• Selecting Methods and type of assays
  • Enzymatic
  • Cellular
  • Microbial
  • Animal Studies
• Feasibility and Optimization Parameters
• Standards and Controls
• Eliminating Edge and Hook Effects
• Setting System Suitability Criteria

Phase I/II Qualification

Pre-validation:

• Improving Ruggedness
• Parallelism
• Process Controls
• Setting Realistic Specs for Validation

Validation

Hands-On Workshop: Validation Protocol for GMP Potency Bioassays

Bioanalytical Assays: PK, Immunogenicity and Biomarkers

• Typical technologies: ELISA, RIA, Biacore, Electrochemoluminescence

Non-Analytical Limits Tests for Bioprocessing Contaminants (i.e., qPCR)

Hands-On Workshop: GLP PK Validation Protocol and Immunogenicity Validation Protocol

Understanding & Planning for Bioassay Method Transfers

Course Instructor

Ana T. Menendez, Ph. D., Senior Director, Bioassay & Biosafety Testing, Catalent Pharma Solutions
Ana T. Menendez, Ph.D., is responsible for the release tests required to verify the functionality and purity of biotechnology products and the complex processes involved in their manufacture. Dr. Menendez joined Catalent from Bristol-Myers Squibb (BMS) where she held a number of positions of increasing responsibility from 1995 to 2001 as the head of the Cancer Cell Biology department. Dr. Menendez obtained her Ph.D. in Microbiology/Immunology in 1995 from N.Y. Medical College while simultaneously fulfilling her supervisory functions at Wyeth. She is an international instructor on Bioassay Method Development and Validation and is a frequent speaker at biopharmaceutical conferences.

Gwen Wise-Blackman, Ph.D., Senior Manager, Cellular Technologies, Catalent Pharma Solutions
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 in 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 received her Ph.D. in Pharmacology from the University of Virginia and her Bachelor of Science in Biology from MIT.