BEBPA Blog
As part of BEBPA’s mandate to provide forums to foster scientific discussion among biopharmaceutical scientists, we actively write up the results of these discussions. These written updates come in the form of White papers written by a committee of scientists, the results of live interactive surveys and occasionally written reports by attendees. These reports are made available to the public and can be downloaded freely.
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
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,
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
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
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.
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
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
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,
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