A-Z Index
Image Cart
              

 Information For:

Manufacturers

Regulator

Healthcare

Consumers

Members

USP Bioassay Workshop

August 13-14, 2008
USP Headquarters, Rockville, Maryland

Bioassays continue to play an essential role in drug development and in many phases of the pharmaceutical product lifecycle. This workshop will address USP General Chapters on the Design, Development, Analysis and Validation of Bioassays. The development, analysis, and validation of bioassays typically require teams of scientists, technicians and statisticians to move a bioassay from development to practice. The new USP chapters and this workshop will provide best-practice guidelines to facilitate this process. The workshop will also explore the role of bioassays in monographs, the transition from animal assays to cell based assays, and bioassays for potency and immunogenicity testing. This interactive event will not only provide guidance and information on bioassays, but will also provide an opportunity for vigorous discussion of the compendial proposals. Upon completion of this two-day program, participants should be able to:

  1. describe the proposed changes to USP General Chapter <111> Analysis of Bioassays;
  2. discuss the two new USP General Chapters <1032> Design and Development Bioassays and <1033> Validation of Bioassays;
  3. evaluate a new approach to the determination of linearity and similarity (parallelism);
  4. compare and contrast the USP and EP approaches to the analysis of bioassays; and
  5. list general requirements for changing from an animal-based assay to a cell based assay.
Download the agenda .

Presentations

(posted on August 23, 2008)

Session I: Analysis of Bioassays
  • Analysis of Bioassays: Robert Capen, Ph.D.
  • Overview of USP Bioassay Chapters and Focus on Chapter <111>, Analysis of Bioassay Data: Robert Singer, M.S.
  • Equivalence Approach for Parallelism and Linearity: Walter W. Hauck, Ph.D.
  • Nonlinear Systems: A Comparison of Approaches to Similarity Testing: John R. Dunn, Ph.D.
  • Analysis of Bioassays, European Perspective: Rose Gaines Das, Ph.D.
  • Regulatory Perspective on Potency Assays for Biological Therapeutics: Susan L. Kirshner, Ph.D.

Session II: Design, Development and Validation of Bioassays
  • <1033> Validation of Bioassays: Chapter Review: Tim Schofield, M.S.
  • Validation Of Bioassays in Practice: Michael G. Mulkerrin, Ph.D.
  • Dilutional Linearity: Janice D. Callahan, Ph.D.
  • <1032> Design and Development of Bioassays: Larry Callahan, Ph.D.
  • How to determine parallelism (similarity), Real life examples: Niels Zeuthen, M.S.

Session III: Bioassays in Practice
  • When are Bioassays necessary and when not? Adrian F. Bristow, Ph.D.
  • DOE in Bioassay Development: Stanley M. Deming, Ph.D.
  • Enzyme (Lipase) Assays, Pancreatic Enzyme Replacement Products: Frédéric Carrière, Ph.D.
  • Animal Bioassay Overview, Insulin Bioassays: Karen Roberts, M.S.
  • Insulin Bioassays, Cell Based Assays: Sriram Akundi, Ph.D.

Session IV: Bioassays for Potency and Immunogenicity
  • Development and Validation of Cell Proliferation Assay for Somatropin: Young-Phil Lee, Ph.D.
  • Interferon Bioassays: Raymond Donnelly, Ph.D.
  • Bioassays in Immunogenicity Testing: Shalini Gupta, Ph.D.
  • Standardization of Neutralization Bioassay for Interferons and other Cytokines: Sidney Grossberg, M.D.