BioPharmaceutical Emerging Best Practices Association

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Tech Briefing: New-“ish” to Potency Bioassays

Many of the industry and regulatory guidelines, highlight the importance of robust development practices for analytical methods. One such guidance is the ICHQ14 Analytical Procedure Development. For first in class, novel biotech products, also known as Advanced Therapeutic Medicine Product (ATMP), this can mean developing radically new and unique assay systems/platforms, utilizing rare and not commercially available biological reagents. Firms working on novel ATMPs are usually staffed with subject matter experts who are well-educated and skilled in the biology of their product. This results in wonderful assays with the critical link to the Mechanism of Action (MoA) of the product. However, they are typically not honed to become Quality Control assays designed to provide reportable values to support product release by assessing whether a particular batch meets potency specifications. 

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.