Critical reagents are essential components of analytical methods whose unique characteristics are crucial to assay performance. The 2018 FDA Bioanalytical Method Validation Guidance for Industry specifically calls out the need to appropriately characterize and document critical reagents.
KCAS performs conjugations of reagents for pharmacokinetic assays as well as immunogenicity assays. The scientists at KCAS understand the importance of critical reagents in the long-term use of the bioanalytical methods. KCAS utilizes skills in both pharmaceutical and biopharmaceutical departments to ensure sufficient information is obtained regarding these important reagents (1).
In conjunction with the bioanalytical method support, we can generate characterization data, and monitor your critical reagent quality. KCAS has orthogonal methods to perform initial characterization and subsequent monitoring of these important reagents.
(1): O’Hara, Theobald, Clement-Egan, et. al. “Ligand Binding Assays in the 21st Century Laboratory: Recommendations for the Characterization and Supply of Critical Reagents”. AAPSJ 2012, 14(2) pp 316-328