USP held an open public discussion of the new bioassay approaches in a Bioassay Workshop in August 2008 at USP Headquarters
in Rockville, MD. USP will hold a similar workshop from August 12–13, 2009, at the same venue. The 2009 meeting will seek
to further engage stakeholders by expanding and building on the progress made on USP's developing collection of bioassay guidance
chapters. Attendees will have an opportunity to discuss chapters <1033> and <1034> with the expert drafting group and will
hear an update about the development of chapter <1032>. In addition, the workshop will again provide a forum for scientific
presentations and dialog among bioassay experts in the bioassay community. Special product-specific focus areas this year
include bioassays for monoclonal antibodies and vaccines. To prepare a scientifically challenging and productive event, USP
would like to hear from members of the bioassay community. What topics should appear on the agenda for this August? Stakeholders
can submit ideas by email to tsm@usp.org . Please use the subject line: "Ideas: Bioassay Workshop 2009." Information regarding registration and meeting logistics will
be available from meetings@usp.org .
CONCLUSION
As ongoing advances in biochemical and biophysical characterization continue to illuminate the molecular features of biological
molecules, the measurement of biological potency will help establish structure–function correlations, assist in determining
of immunologic response, and elucidate the molecule's biological identity. Most importantly, stability in potency results
assures practitioners and patients that they are receiving a product with consistency in anticipated therapeutic outcomes
batch-after-batch over many years following market access. For multiple products under the same name, the bioassay should
also assist in ensuring comparable potency across manufacturers making the same ingredient or product. To this end, USP continues
to work with stakeholders to provide state-of the art bioanalytical tools for compendial scientists.
Tina S. Morris, PhD, is vice president of Biologics & Biotechnology, Robert Singer is chair, Bioassay Ad Hoc Advisory Panel and founding Member of Biometry Associates LLC, Union City, CA, Michael R. Ambrose, PhD, is director, Biologics & Biotechnology Laboratory, and Walter W. Hauck, PhD, is senior scientific fellow, all at United States Pharmacopeia, Rockville, MD, 301.816.8377, tsm@usp.org .
REFERENCES
1. Hauck WW, et al. Summary of planned revisions to design and analysis of biological assays <111>. Pharm Forum. 2007:33(3);580–81.
2. <111> Design and Analysis of Biological Assays. Pharm Forum. 2008 34(3):685–735.
Tina S. Morris, PhD, is vice president of Biologics & Biotechnology at United States Pharmacopeia (USP)
Articles by Tina S. Morris, PhD
Robert Singer
Robert Singer is chair, Bioassay Ad Hoc Advisory Panel at United States Pharmacopeia, and founding Member of Biometry Associates LLC, Union City, CA,
Articles by Robert Singer
Michael R. Ambrose, PhD
Michael R. Ambrose, PhD, is director, Biologics & Biotechnology Laboratory at United States Pharmacopeia
Articles by Michael R. Ambrose, PhD
