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.

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 acceptable level sometimes can be challenging because of the diverse nature of the HCPs and their potential affinity for the intended product, especially for non-monoclonal antibody (non-mAb) products due to the lack of affinity purification process.