Fit-for-purpose biomarker immunoassay qualification and validation: three case studies. (November 2016)

• Record Type: Journal Article
• Authors: Cowan, Kyra; Gao, Xiaoying; Parab, Vaishali; Nguy, Trung; Wu, Lawren; Arron, Joseph R; Townsend, Michael; Wallin, Jeffrey; Cheu, Melissa; Morimoto, Alyssa; Wakshull, Eric
• Is Part Of: Bioanalysis. Volume 8:Number 22(2016)
• Page Start: 2329
• Page End: 2340
• Publication Date: 2016-11
• Subjects: assay -- biomarker -- development -- FFP -- qualification -- validation; Drugs -- Analysis -- Periodicals; 615.19005
• DOI: 10.4155/bio-2016-0184
• Languages: English
• ISSNs: 1757-6180

Abstract

Aim: To improve on the efficiency of biomarker assay readiness, and for reliable biomarker data to support three drug programs, we implemented a fit-for-purpose approach, qualifying two biomarker assays and validating a third.Results/methodology: The qualification strategy and selection of experiments for two exploratory biomarkers (CXCL1, CCL19) was determined by the intended use of the biomarker data. The third biomarker, IL-6, was validated as the data would be used in monitoring patient safety during dose-escalation studies in a Phase I trial. All three assays passed a priori acceptance criteria.Conclusion: These assays highlight strategies and methodologies for a fit-for-purpose approach. Minimum qualification, full qualification and validation were chosen and supported programs at different stages of drug development.