title: Fit-for-purpose biomarker immunoassay qualification and validation: three case studies.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Genentech, 1 DNA Way, South San Francisco, CA 94080, USA.
authors.forename: Kyra
authors.initials: K
authors.lastname: Cowan
authors.affiliation: Genentech, 1 DNA Way, South San Francisco, CA 94080, USA.
authors.forename: Xiaoying
authors.initials: X
authors.lastname: Gao
authors.affiliation: Merck & Co, Inc., 901 South California Ave, Palo Alto, CA 94304, USA.
authors.forename: Vaishali
authors.initials: V
authors.lastname: Parab
authors.affiliation: Genentech, 1 DNA Way, South San Francisco, CA 94080, USA.
authors.forename: Trung
authors.initials: T
authors.lastname: Nguy
authors.affiliation: Amgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA 91320, USA.
authors.forename: Lawren
authors.initials: L
authors.lastname: Wu
authors.affiliation: Genentech, 1 DNA Way, South San Francisco, CA 94080, USA.
authors.forename: Joseph R
authors.initials: JR
authors.lastname: Arron
authors.affiliation: Genentech, 1 DNA Way, South San Francisco, CA 94080, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Townsend
authors.affiliation: Genentech, 1 DNA Way, South San Francisco, CA 94080, USA.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Wallin
authors.affiliation: Genentech, 1 DNA Way, South San Francisco, CA 94080, USA.
authors.forename: Melissa
authors.initials: M
authors.lastname: Cheu
authors.affiliation: Genentech, 1 DNA Way, South San Francisco, CA 94080, USA.
authors.forename: Alyssa
authors.initials: A
authors.lastname: Morimoto
authors.affiliation: Genentech, 1 DNA Way, South San Francisco, CA 94080, USA.
authors.forename: Eric
authors.initials: E
authors.lastname: Wakshull
keywords: FFP; assay; biomarker; development; qualification; validation