The Role of USP Chapters in Bioassay Development and Validation
Volume 1, Issue 10: Design, development and validation of bioassays has been part of the USP/NF for nearly 50 years. The chapters are regularly reviewed and revised by the Statistics Expert Committee.
Tech Briefing: The Wonderful World of Automation and Artificial Intelligence in the Bioassay Lab
At BEBPA we track implementation of new technologies, analysis approaches and the emergence of new technologies in the potency bioassay world. Over the past years, we have seen a steady increase in the use of frozen-ready-to-use cells, development of reporter gene assays and the increased use of automation
Tech Briefing: Want to Question Authority? Develop a Bioassay!
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.
Tech Briefing: Bioassay for Complex Products: You have come a long way, baby.
Remember when a monoclonal antibody (mAb) was considered a “complex” product? A mere 30 years ago! As we gained experience with these molecules, we transitioned from complex products to referring to them as large molecules and then finally they become Well-Characteriized Biotech Products (WCBP). This transition is not mere wordsmithing but has distinct regulatory ramifications. Becoming a WCBP was a major step in moving away from the “product is the process”.
Critical HCPs: What to do with them?
Volume 1, Issue 9: Host cell proteins (HCPs) are a complex blend of various proteins that need to be depleted during the production of biotherapeutics. Any residual HCPs can pose diverse risks to quality, safety, and developability of a drug. There is manufacturing and clinical history indicating certain classes of HCPs which have been problematic, e.g. HCPs which,
2024 EUB Conference Survey Results (PDF)
BEBPA Blog 2024 EUB Conference Survey Results (PDF) View PDF Survey
Reference Standards for Potency Assays: White Paper
Thank you to those that attended BEBPA’s Virtual Reference Material Conference in June 2024. Due to time limitations there were some unanswered questions at the end of Conference Days 2 and 3. Nobody likes unanswered questions! So we asked our speakers to provide answers. You can find them listed below.
FDA Federal Register: Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products
The FDA has posted a request for information and comments in the Federal Register on the subject Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products. BEBPA strongly encourages participation in this process. Comments will close on September 23, 2024.
Host Cell Proteins Remain a Hotly Debated and Emerging Topic
Volume 1, Issue 8: At the finish of the recent 12th annual Host Cell Protein Conference (May 14-16, 2024) sponsored by BEBPA in College Park, MD, Dr. Denise Krawitz gave her final summary of conference highlights. We thought it would be fun and informative for those of you who could not join us to hear a synopsis of the 3-day conference from her perspective. Below you will find excerpts from her summary:
Virtual Reference Material Conference: Your Questions Answered
Thank you to those that attended BEBPA’s Virtual Reference Material Conference in June 2024. Due to time limitations there were some unanswered questions at the end of Conference Days 2 and 3. Nobody likes unanswered questions! So we asked our speakers to provide answers. You can find them listed below.