Design of biomarker validation for intended use in drug development
Insulin assays have been used for decades, and although they were validated once upon a time, industry guidelines have since been updated, improved and changed. How do these old methods stand against modern needs and requirements?
The Mercodia Insulin ELISA, available on the market for more than 20 years, was re-validated for intended use in drug development programs in relation to FDA, EMA and CLSI guidelines. A biomarker validation in relation to FDA and EMA guidelines puts high demands on the validation design, given the aim of the guidelines is mainly to guide pharmacokinetic (PK) studies and not necessarily to guide validation of biomarkers. Native insulin or insulin analogues are present in all donor matrices. In addition, the use and/or development of insulin analogues pose a special challenge of specificity given the similarity between molecules. This adds additional demands on the assay validation as it must be designed to show if the method is fit for purpose or not.
The completed validation showed an insulin assay with well-characterized performance. It fulfils the requirements for precision, accuracy, sensitivity selectivity and specificity, and is, thereby, a good choice when insulin levels need to be assessed in any phase of drug development.
