BEBPA Blog
Tech Briefing: Want to Question Authority? Develop a Bioassay!
By Laureen Little, Principal Consultant, Quality Services and President (BEBPA)
A hallmark of a potency bioassay is that it is guaranteed to be different from any bioassay ever developed previously….or is it? (Ah here we go already questioning authority!) Are platform potency bioassays possible? Perhaps? At the upcoming BEBPA US Bioassay Conference happening in Tucson, AZ March 24 to 26, 2025 Biogen will be discussing their FRET platform and its use with a wide range of protein products.
Potency assays are needed to support CQA testing and release of protein therapeutic programs. Large portfolios often require simultaneous support of multiple programs each with multiple binding assays. To streamline assay development, we established a FRET platform that significantly simplifies development timelines and standardizes qualifications for antigen and Fc binding assays. This platform leverages Hamilton STAR automation to test binding of multiple targets in a single run. This streamlined approach has enhanced efficiency and reproducibility and paved the way for more rapid and reliable assay development.
Perhaps your firm doesn’t have protein products which bind antigens which fit into a platform approach as outlined above. Does this mean one has to re-invent the wheel with each assay? BEBPA has asked a major biopharma company with multiple approved products and a big pipeline of various products, how they address this problem. The answer? Utilize a standard approach to bioassay development even though there are widely different biological systems. They have submitted a working title of: Acceleration of Potency Assay Development Utilizing a Standard Approach. We will let you know when the abstract is finalized by their legal department and we can share the entire abstract.
The bottom line, is that although as an industry we develop a variety of products, with hundreds of different Mechanisms of Actions (MoAs), we are implementing common approaches, and have many common problems.
Join us at the upcoming BEBPA US Bioassay Conference in Tucson, AZ March 24 to 26, 2025. You will hear many case studies about many assay types including: Flow Cytometry, Cell Migration, Enzymatic assays, Bioluminescent assays and many more. These methods are used to support a multiplicity of products including cellular therapies, gene therapies, Antibody-Drug Conjugates, mAb products, CAR-T products and many others. These presentations are by your colleagues and are always filled with new ideas and great ideas about how to accelerate your development projects. Sign up soon before the price goes up and hotel room discounts sell out.