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 have the most prescriptive documents.
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 about how to assure product potency during clinical trials and later during the commercial phase. A look at the two most common of the new modalities; gene therapy (GT) and cell therapy (CT) gives one an idea of the wide varying issues. A gene therapy product with a single expressed protein might have a single mechanism of action (MoA).
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, 2025 in Tucson, AZ. We asked her about what she sees is happening in the potency field.
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 similarly vital importance. Biologic drugs are highly complex and impurities can arise during production, purification, and storage. Unlike small-molecule drugs, biologics are susceptible to a wide range of contaminants—including host cell proteins, endotoxins, and other bioactive substances that can affect their safety, efficacy, and stability. Detecting these impurities requires robust analytical tools, and bioassays can play a central role in the quality control of these products.
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 and data scientists, anybody with a little bit of time on their hand can train themselves into becoming a “prompt engineer” and call themselves an expert within weeks (hours?) of their learning journey. This short article aims to raise awareness about how impactful AI can be for the pharmaceutical industry and especially for assay scientists.
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 suitable for its intended purpose. Indeed validation, has a long history within the pharmaceutical industry. Approximately twenty years ago (1994 and 1996), the International Council for Harmonisation (ICH) first published two guidelines for the Validation of Analytical Methods in two documents ICH Q2A and ICH Q2B. The first document was a list of definitions and terminology, the second was a how-to guideline.
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”.