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Cutting-edge approaches to ensuring biologic drug quality focus of forum on bioassays
Date:11/16/2012

e manufacturing processes for biologics are continuously changing throughout the development and life cycle of a biologic drug, bioassays are important for maintaining the integrity of a drug's potency and for determining that the drug is continuing to work in the manner in which it is intended.

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 standardsUnited States Pharmacopeia and the National Formulary (USPNF). 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 pr
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Contact: Theresa Laranang-Mutlu
trl@usp.org
301-816-8167
US Pharmacopeia
Source:Eurekalert

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