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.
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 standards-United States Pharmacopeia and the National Formulary (USP-NF). 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 product also is very important. Strategies for monitoring and replacing these materials will be highlighted during the workshop.
The workshop also will provide attendees with a unique opportunity to interact with vendors of bioassay development software. In addition to an open-forum Q&A session with software vendors, one-on-one discussion sessions with vendors will allow users to elaborate on their own in-house needs and determine how specific software offerings can address them.