Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis

Another paper from our biomarker and bioanalysis team for you this week!

📑 Read it here: https://hubs.la/Q01rH3Kr0

In this white paper, first-author Rafiq Islam, VP of Bioanalysis and Biomarkers at Amador Bioscience, addresses the views of The Global Contract Research Organization Council for Bioanalysis (GCC). The GCC provides recommendations on hot topics of global interest in small- and large-molecule bioanalysis, biomarkers and immunogenicity advocating for productive dialogues between manufacturers and customers which would help to generate quality data for regulatory decision making.

Biomarker data has become an essential part of drug development and companies and regulatory agencies are making decisions based on biomarker results. In this white paper the GCC discusses the challenges of using commercial biomarker kits in drug development for bioanalysis, providing a framework for the creation of “Drug Development Kits” adapted to the needs of biomarker work that could be used for the development of drug applications for regulatory submission.

The demand for commercial kits has grown with the demand for biomarker analysis. However, commercially available kits were not designed for drug development. And, to comply with regulatory requirements they must be adapted by bioanalytical laboratories' prior assay validation.

The implementation of the GCC recommendations may encourage the inclusion of validated quality biomarker data in drug application dossiers to facilitate regulatory approval.

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