Evaluation of Rapid Microbiological Methods for Quality Release Testing of Biopharmaceutical Products

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Abstract

During this fiscal year, we published a minireview that highlights the IOPQ requirements for equipment management which is an important part of any cGMP program. The insights provided in this paper would have also been relevant to clinical microbiology labs performing laboratory developed tests (prior to the annullment of the FDA ruling in March 2025). We have published a Comparative Evaluation of Microbiologics EZ-Accushot and bioMerieux Bioballs for Media Qualification Testing. The data in this paper is relevant for both the pharmaceutical and clinical fields, and highlights the criticality of assessing quality internally without sole reliance on the manufacturer's certificate of analysis. We have participated in a inter-laboratory study (11 labs) to evaluate the performance of 8 different sterility testing platforms using a standardized sample set. The results are surprising and fill a significant gap in the scientific literature which will be beneficial for the biopharma industry and FDA regulators. The results of this study are in manuscript draft.