Biological Potency Assays are Key to Assessing Product Consistency - Modern bioassays enable more accurate potency testing. - BioPharm International

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Biological Potency Assays are Key to Assessing Product Consistency
Modern bioassays enable more accurate potency testing.


BioPharm International
Volume 22, Issue 6

OPEN SCIENTIFIC DISCOURSE

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
. Please use the subject line: "Ideas: Bioassay Workshop 2009." Information regarding registration and meeting logistics will be available from
.

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,
.

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.


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