title: Best practice recommendations for the transfer of cell-based assays for the measurement of neutralizing anti-drug antibodies.
abstract: We recommend the application of a strategically designed step-wise approach to transfer cell-based assays that includes assessing analytical performance (through a fit for purpose validation and/or design of experiment robustness characterization), clinical performance (i.e., concordance) and performance or proficiency testing for long-term method monitoring. Here we focus on the application of this strategy to cell-based assays for the measurement of neutralizing anti-drug antibodies. This application is unique in that it requires a custom cell-based assay to be used over a long period of time (potentially phase 1a through the life of a marketed product) with the confidence of consistent method performance and result reporting. But, the process is adaptable to a variety of assay types and applications. We present lessons learned from two cell-based assay transfers that met relevant challenges while implementing alternative permutations of the recommended method transfer process.
authors: Xencor, Inc., 111 W Lemon Ave, Floor 2, Monrovia, CA 91016, USA.
authors: Shelley S
authors: SS
authors: Belouski
authors: Danika
authors: D
authors: Born
authors: Amgen, Inc., Thousand Oaks, CA, USA.
authors: Susan
authors: S
authors: Jacques
authors: Genentech, Antibody Way, Oceanside, CA 92056, USA.
authors: Brandon
authors: B
authors: Harder
authors: Reynhardt Consulting, LLC, 2033 2nd Ave Apt 800, Seattle, WA 98121-2245, USA.
authors: Kai
authors: K
authors: Reynhardt
authors: Amgen, Inc., Thousand Oaks, CA, USA.
authors: Arunan
authors: A
authors: Kaliyaperumal
authors: Amgen, Inc., Thousand Oaks, CA, USA.
authors: Shalini
authors: S
authors: Gupta
mesh_terms: D000818:Animals; D057134:Antibodies, Neutralizing / Q000032:analysis*; D018929:Cell Culture Techniques / Q000379:methods*; D016207:Cytokines / Q000032:analysis; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D005069:Evaluation Studies as Topic; D006801:Humans
chemical_list: D057134:Antibodies, Neutralizing; D016207:Cytokines
keywords: cell-based assays; immunogenicity; method validation and method transfer; neutralizing antibodies