Method Optimization: Assay Development Following Compendial Methods
Chapter 621 of the USP explains the allowable adjustments to chromatography systems while staying within quality requirements. It is important to consider these criteria before beginning to optimize assays for APIs and related substances to ensure that methods meet requirements during regulatory filing.
In this case, Cambrex had a short time frame of only 7 weeks to complete assay optimization and conduct pre-validation studies within the confines of USP<621>.
To learn how Cambrex was able to meet the client’s timeline while facing additional challenges from inherent properties of the API, read our full case study.