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. 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.

Instructor

Ana T. Menendez, Ph.D., Sr. 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.

Course Agenda

• GMP and GLP Overview
• Development
  • selecting methods and types of assays
  • feasibility and optimization parameters
  • standards and controls
  • eliminating edge and hook effects
  • setting system suitability criteria
• Phase I/II Qualification
  • Implementing the new USP Bioassay suite: 1032, 1033 and 1034
• Pre-Validation:
  • choosing traditional parallelism or similarity
  • setting realistic specs for validation
  • process control chart exercise
• Validation Protocol Workshop for GMP Potency Bioassays
• Pharmacokinetic Immunoassays
  • implementing current guidances including incurred sample reanalysis
• Immunogenicity: Binding Assays & Neutralization Assays
  • strategies to meet EMA, FDA and industry expectations
  • hands-on cut-point exercise
• Limits Tests, including qPCR technology
• Method Transfer