BEBPA Blog
Category: Bioassay
Tech Briefing: Relative Potency Assays: Parallel Line vs. Slope Ratio Assays
Although the potency bioassay is considered a critical analytical method, finding regulatory guidelines which answer practical questions can be difficult. The pharmacopeia, USP and EP
Tech Briefing: Bioassays For New Product Modalities
As a staring place, this is not a bad effort at defining new modalities. The widely varying product types highlights the scope of the problem
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
Volume 2, Issue 3: Bioassays are used extensively for potency determination of biologic therapeutics. However, ensuring the purity and safety of biologic drugs is of
AI in Bioassay: The Good, The Bad, The Ugly.
Volume 2, Issue 2: For decades, the study and development of AI was reserved to high level academics. Today, much to the amusement of statisticians
Characterization of Precision and Accuracy and Total Analytical Error for Bioassays
Volume 2, Issue 1: We tend to think analytical validation is a fairly straight forward, almost box checking activity if a method is well-developed and
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