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Bioassay Workshop

August 12 – 13, 2009
USP Headquarters, Rockville, Maryland

Overview

Bioassays play an integral part in the development and product lifecycle of nearly all biotechnology–derived products. Building on USP's successful 2008 workshop, this year's edition intends to further inform stakeholders on USP’s emerging suite of general bioassay guidance and also further explore the most important issues that analysts encounter in product– or product–class specific bioassays.

On Day 1:

  • Discuss the new USP Chapter <1033> Validation of Biological Assays with the drafting group of experts
  • Hear about Chapter <1034> Analysis of Biological Assays
  • Get a preview of Chapter <1032> Design of Biological Assays

The format of these sessions will be highly interactive to allow participants to enjoy an open discussion with the expert panelists.

On Day 2:
Hear about highly relevant product– and assay–specific topics:

  • the replacement of animal–based bioassays with second–generation cell–based and binding tests
  • the challenges of product–specific assays for both well characterized (e.g. monoclonal antibodies) and complex (e.g. vaccine) products
  • the role of bioassays in the determination of unwanted immunogenicity

Agenda

Click here  (51KB) for the final agenda

Presentations

Contact Information

For additional information or support, email .