BioPharmaceutical Emerging Best Practices Association

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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”.

Tech Briefing: Regulatory Guidances for Potency Assays

The potency bioassay is a keystone assay supporting the regulatory quality assurance strategy for verifying that products released for commercial use have similar biological activity to those used in clinical trials to demonstrate efficacy. We routinely gather at the annual BEBPA European Bioassay Conference to discuss the best scientific practices for developing potency assays.

Tech Briefing: How Good is Good Enough?

How good is good enough? As scientists we are trained to make our assays not just good but the best. However, sometimes taking that last step, going from good to best is a nearly impossible feat and requires more resources than it took to develop the assay in the first place. That brings us back to how good is good enough? (Hint, the answer is NOT: “good enough to pass regulatory scrutiny”). A typical answer, most of us can chant the phrase is that it must be “suitable for use”.

Tech Briefing: The Importance Of Being Potent (with apologies to Oscar Wilde)

The need for potency assays for biopharmaceutical therapeutics has been recognized for some time. The regulatory agencies from all ICH-abiding countries require one or more potency assays as part of the release suite of assays associated with DS and DP. Entire programs have been put on clinical hold for lack of a well-reasoned and supported potency assay.

Tech Briefing: Use of Design of Experiment (DOE) for Bioassay Development

Doing more with fewer resources is the name of the game in any business. One of the best tools for cutting through the early stages of assay development, when one doesn’t know what assay parameters are critical and which aren’t, is the use of a multifactorial design of experiments (DOE). DOE allows assessment of multiple factors rather than the traditional “one-factor-at-a-time” (OFAT) approach.