Published on November 17, 2012 at 3:48 AM
Cell-based assays will be one of the topics discussed at the USP Bioassay Workshop. USP's current activities in this area include standards development for biological medicines involving cell-based assays to measure erythropoietin bioactivity and somatropin cell-based bioidentity methods. Emerging technologies are making it possible for manufacturers to consider novel methods for measuring a drug's potency. Compared to traditional animal-based testing, some newer cell-based assays are enabling more precise measurements of potency and drug activity and are proving to be easier to execute in the laboratory. However, manufacturers must be able to demonstrate that newer, cell-based assays are suitable replacements for older methods based on clinical and safety data obtained using previous assays and clinical trial batches of the drug. Regulatory perspectives on the implementation of new methods will also be discussed.
In August 2012, a suite of standards known as the "USP Bioassay Chapters" became official in USP's published compendia of standards-United States Pharmacopeia and the National Formulary (USP-NF). The December workshop will feature a session dedicated to the USP Bioassay Chapters and will include presentations on user feedback regarding their applicability to bioassay development and validation during drug development and post-licensure stages. Perspectives on bioassay challenges from the U.S. Food and Drug Administration (FDA) also will be featured during this session.
While great emphasis is placed on validation and use of bioassay methods, the qualification of critical reagents and references materials used during the life cycle of a product also is very important. Strategies for monitoring and replacing these materials will be highlighted during the workshop.
The workshop also will provide attendees with a unique opportunity to interact with vendors of bioassay development software. In addition to an open-forum Q&A session with software vendors, one-on-one discussion sessions with vendors will allow users to elaborate on their own in-house needs and determine how specific software offerings can address them.
Source: US Pharmacopeia