Managing critical reagents through drug development 

Critical reagents are instrumental to large molecule drug development. They constitute a key element in the bioanalytical assay for the quantitative determination of the test compound. Companies often find it challenging to produce and manage lots of consistent quality, even though such consistency governs the accuracy, precision and robustness of the assay.

Critical reagents and their role in bioanalytical studies

ICH M10, draft guidance from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), states that critical reagents and binding agents, i.e., binding proteins, aptamers, antibodies or conjugated antibodies, directly impact assay results, thus ensuring their quality is paramount. According to the guidelines, “Critical reagents bind the analyte and, upon interaction, lead to an instrument signal corresponding to the analyte concentration.” 1

Ligand-bind assays (LBAs) are often used to ca…

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