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.
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,
Unveiling Host Cell Protein (HCP) Coverage in Three-Dimensions (3D): Why It Matters and How to Achieve It
Host cell proteins (HCPs) are impurities derived from the host organism used in the production of genetically engineered biopharmaceuticals. Their removal is crucial for the
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
Tech Briefing: Beyond the Surface: Is Going Deeper Always More Beneficial?
Host cell proteins (HCPs) are residual protein impurities expressed along with the desired biologics product. Removing HCPs in the final drug substance (DS) to an
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