2nd Annual Bioassay Workshop

Bioassays play an integral part in the development and product lifecycle of nearly all biotechnology-derived products. Building on USP's successful 2008 workshop, the 2009 session further informed stakeholders on USP’s emerging suite of general bioassay guidance and also further explored the most important issues that analysts encounter in product or product-class specific bioassays.

Topics:

  • USP General Chapter <1033> Validation of Biological Assays
  • USP General Chapter <1034> Analysis of Biological Assays
  • Preview USP General Chapter <1032> Design of Biological Assays
  • Replacement of animal-based bioassays with second-generation cell-based
    and binding tests
  • Challenges of product-specific assays for both well characterized (e.g. monoclonal antibodies) and complex (e.g. vaccine) products
  • Role of bioassays in the determination of unwanted immunogenicity

When: August 12–13, 2009

Where: USP Headquarters; Rockville, MD, USA

Agenda

Presentations:

Participants: Professionals working in or with

  • Bioassay Practitioners
  • Biostatisticians
  • Bioassay Software Experts
  • Pharmaceutical Industry Professionals
  • Biopharmaceutical Industry Professionals
  • Biotechnology Industry Professionals