Qualification of critical reagents in in-vitro potency bioassays using Curve Parameter Control Strategy

Debby Bartfeld, NA, Independent consultant, Mazkeret Batya, Israel (debby@bartfeld.net)

Developing an in-vitro potency bioassay requires the identification, characterization, qualification and stability monitoring of key critical reagents, which may influence the assay performance.  In the last few years, critical reagents have become a focal point of concern for regulatory agencies such as the FDA. Currently, there is no specific guidance on qualifying new reagent lots or monitoring their stability throughout their lifecycle. In the absence of such guidance, agencies often mandate extensive validation procedures, including the assessment of potency comparability between current and new reagent lots across the assay’s potency range, necessitating a statistically significant number of test samples (20-30). This requirement imposes a considerable burden on the QC laboratory without providing substantial value, given the inherent robustness of in-vitro relative potency assays to changes in critical reagents.

In this presentation, an alternative strategy for qualifying new critical reagent lots in in-vitro potency assay, termed the "Curve Parameter Control Strategy" is proposed. This approach significantly reduces the QC laboratory workload while providing an efficient means for qualification and control of critical reagents. This strategy enables real-time detection of potential deterioration in reagent quality, facilitates immediate corrective actions, thereby enhancing assay reliability and regulatory compliance.

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Short Biography of Presenting Author

Dr. Debby Bartfeld is an independent consultant specializing in analytical chemistry and biochemistry for the biotech and pharmaceutical industry. She holds a BSc in Chemistry and an MSc in Analytical Chemistry from the Hebrew University of Jerusalem, as well as a PhD in Structural Biology from the Weizmann Institute of Science. Dr. Bartfeld has accumulated 30 years of experience in analytical chemistry and biochemistry within the pharmaceutical sector at ArQule, NitroMed, and Vertex Pharmaceuticals in the USA, as well as BTG, MediWound, and SciVac in Israel. Her expertise encompasses small molecules, peptides, protein therapeutics, complex biological products from botanical sources, and vaccines. She has contributed to all stages of analytical drug development, from early discovery and preclinical testing to clinical trials and regulatory submissions for marketing and post marketing authorizations.