As a growing number of biologic drugs are treatments of choice for an expanding list of autoimmune disorders, inflammatory diseases, and certain cancers, bioassays play a critical role in establishing the functional integrity and potency of these products. Hosted by the United States Pharmacopeial Convention (USP), the Fifth Bioassay Workshop will take place on December 4-5, 2012, at USP's headquarters in Rockville, Md. The workshop will focus on the development, monitoring and validation/revalidation of bioassays. It will feature perspectives from manufacturers, regulators and other stakeholders on such topics as the replacement of animal-based assays with cell-based assays; USP's standards for bioassays; software selection for bioassay development and other related topics.
According to Roger L. Williams, M.D., chief executive officer of USP, "Developing standards for modern medicines such as biologics is a complicated yet important undertaking. Through forums like USP's Fifth Bioassay Workshop, manufacturers, regulators and other stakeholders can exchange ideas and strategies for approaching important issues such as bioassay development. Being able to share information and expertise undergirds our ability to create standards that help to ensure the quality of the global drug supply."
Conventional pharmaceuticals are made through chemical routes and have small molecular structures. Biologics-particularly more modern ones such as recombinant proteins and monoclonal antibodies-are larger and more complex in their makeup, and are derived from living cells or organisms. As a result, it is not possible to fully characterize biologic drugs in the same way that chemical drugs are characterized using commonly-applied analytical techniques and procedures. Bioassays are used to assign or confirm drug potency and to validate that a drug is functioning as expected, usually by comparison to a known reference standard. Since 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.