Lot-to-lot reproducibility, stability and life cycle management of antibody reagents for flow cytometry

Lanham DF | Bioanalysis, 13(10), 745–759 (2021) Keywords: assay development • critical reagents • drug development • flow cytometry • fluorochromes • life cycle The increasing number of biopharmaceuticals, gene and cell therapies in development has seen a growing use of flow cytometry to measure biomarkers, generate pharmacokinetic data, assess immunogenicity and investigate target engagement. The importance of these data types and their inclusion in regulatory submissions mean that flow cytometry analyses are now expected to demonstrate robust performance and comply with both regulatory and scientific recommendations during their validation and subsequent use in sample analysis. The control of the ‘critical reagents’ commonly...