Institute for International Research

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.

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
  • implementing revised USP 111
• Phase I/II Qualification
• Pre-Validation:
  • ruggedness, parallelism
  • setting realistic specs for validation
  • process control chart exercise
• Validation Protocol Workshop for GMP Potency Bioassays
• Pharmacokinetic Immunoassays
  • incurred sample re-analysis
• Immunogenicity: Binding Assays & Neutralization Assays
  • cut-point exercise
• Limits Tests, including qPCR technology
• Method Transfer

Who Should Attend?

• Bioassay Scientists involved in bioassay execution
• Bioanalytical Scientists
• Validation Specialists
• Project Management Leaders
• Regulatory staff and QA

Instructor

Ana T. Menendez, Ph.D., Senior Director of Biotechnology, Catalent Pharma Solutions
Ana T. Menendez, Ph.D., is Senior Director of Biotechnology at Catalent Pharma Solutions. She implemented various laboratories to verify the functionality, purity and safety of biotechnology products. The GLP/GMP biotesting services at Catalent consists of cellular, molecular, viral and immunological technologies. Dr. Menendez obtained her Ph.D. in Microbiology/Immunology from New York Medical College and joined Catalent from Bristol-Myers Squibb (BMS) where she held a number of positions of increasing responsibility from 1995 to 2001. From 1982 to 1995, Dr. Menendez pioneered monoclonal antibody technology at American Cyanamid/Wyeth and worked on the development of Mylotarg, an anticancer monoclonal antibody-toxin conjugate approved in 2000.