Biologics, Biotechnology Therapies are Focus of Symposium on Drug Quality Standards

Biologics, Biotechnology Therapies are Focus of Symposium on Drug Quality Standards

Product Class Quality, Bioassays, Regulatory Issues Related to Monoclonal Antibodies, Cell Therapies, and Other Biologics to Be Addressed

Rockville, Md., September 6, 2011 - Increasingly used to treat certain advanced-stage cancers, chronic inflammatory diseases, and complex disorders such as cystic fibrosis, biologic and biotechnology products are providing answers to some of the unmet needs for a growing list of diseases. Collectively referred to as "biologics," these therapies are also being used in some cases where traditional medical treatments are no longer viable options for patients. This year, the U.S. Pharmacopeial Convention (USP) will dedicate its annual scientific symposium to the important area of quality standards for biologic and biotechnology-based drugs.

Taking place October 3-6, 2011, in Seattle, Wash., USP's Science & Standards Symposium on Biologics and Biotechnology will open with a keynote event, "How the World Regulates Biologics," featuring Steven Kozlowski, M.D., director of the Office of Biotechnology Products in the Office of Pharmaceutical Science in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA), and Gillian Woollett, Ph.D., chief scientist at the Washington, D.C., law firm Engel & Novitt, LLP. The session will be a point-counterpoint, focusing on biosimilars-drugs similar to and also potentially interchangeable with innovator biologics previously approved by FDA. USP is a private, nonprofit, scientific organization that develops standards for the quality of medicines manufactured or sold in the U.S., and compliance to USP's standards is enforceable by FDA. (For preview video highlights, visit:

"While biologics bring great therapeutic opportunities, their complexity also may create vulnerabilities associated with quality," says Roger L. Williams, M.D., USP's chief executive officer. "As the development, registration, manufacture, and distribution of these important medicines proceed on an increasingly globalized path, it is paramount that involved communities, including patients and practitioners, come together to develop strong quality standards for biologics based on up-to-date scientific knowledge."

This year's Symposium marks a critical time in the development of biologics. In the last decade, regulatory approvals of new biologics nearly doubled over those in the 1990s. Between 2011 and 2015, approximately 30 branded biologics will come off patent, opening up prospects for drug manufacturers and suppliers around the world with their eye on the biosimilars market in the

U.S. In a New England Journal of Medicine article released last month, FDA scientists-including USP keynoter Dr. Kozlowski-outlined key considerations related to FDA's implementation plans for the new statutory approval pathway for medicines FDA deems to be "biosimilar."

 "With traditional small molecule drugs that dominate today's pharmaceutical market, identity, strength and purity-and thus, quality-can be determined in a rather straightforward manner using specific analytical methods and measures," according to Tina Morris, Ph.D., vice president of biologics and biotechnology for USP, and the lead organizer for the meeting. "A biologic, on the other hand, can be a peptide that has a relatively simple structure, or it could be a very complex mixture like the blood thinner, heparin, or a vaccine. Thus, USP relies on forums like the Science & Standards Symposium to conduct an open dialogue with manufacturers about the technical challenges they face related to the quality of these complicated therapies. Whether a scientist is developing a new biotechnology product, or multiple manufacturers are looking for quality guidance and standards for a biosimilar, getting involved in the standards-setting process with USP at the ground-level is critical."

To frame the dialogue on biologics, the Symposium will be divided into two tracks. The first will center on bioassays-procedures that determine the biologic potency of medicinal products. Building on USP's three previous annual workshops geared to professionals in the bioassay and biostatistics fields, this track will focus on:  USP's new guidance on bioassays, scheduled to become official in 2012; sample data sets from industry bioassay case studies; and biological potency reference standards. The second track will address quality attributes of specific biologic product classes, which will include presentations on monoclonal antibodies, post-translational modifications to proteins, enzyme measurement, and ancillary materials (i.e., materials used in the production of some biologics that are generally not intended to remain in a final product).

To access a complete meeting agenda, speaker biographies, and registration information, visit: For more information, please contact [email protected]


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The United States Pharmacopeial Convention (USP) is a scientific, nonprofit, standards-setting organization that advances public health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. USP's standards are recognized and used worldwide.  For more information about USP visit FY1209