BEBPA Blog
Category: Bioassay
An Interview with BEBPA’s President: Laureen Little, Ph.D.
BEBPA had a chance to sit down with Laureen Little, the President of BEBPA and producer for the upcoming US Bioassay Conference happening March 24-26,
Beyond Potency: Leveraging Bioassays for Contaminant Testing
Bioassays are used extensively for potency determination of biologic therapeutics. However, ensuring the purity and safety of biologic drugs is of similarly vital importance. Biologic
AI in Bioassay: The Good, The Bad, The Ugly.
For decades, the study and development of AI was reserved to high level academics. Today, much to the amusement of statisticians and data scientists, anybody
Characterization of Precision and Accuracy and Total Analytical Error for Bioassays
We tend to think analytical validation is a fairly straight forward, almost box checking activity if a method is well-developed and suitable for its intended
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
2024 EUB Conference Survey Results (PDF)
BEBPA Blog 2024 EUB Conference Survey Results (PDF) View PDF Survey
Tech Briefing: Regulatory Guidances for Potency Assays
The potency bioassay is a keystone assay supporting the regulatory quality assurance strategy for verifying that products released for commercial use have similar biological activity