Current Approaches for ADME Characterization of Antibody-Drug Conjugates: An Industry White Paper

Pharmacokinetics, Dynamics & Metabolism, Pfizer, La Jolla, California (E.K.), Preclinical and Translational Pharmacokinetics and Pharmacodynamics, Genentech, South San Francisco, California (A.V.K.), Drug Metabolism and Pharmacokinetics, Novartis Institutes for BioMedical Research, Novartis Pharma, Basel, Switzerland (M.W.), Drug Metabolism, Pharmacokinetics & Bioanalysis Department, AbbVie, Worcester, Massachusetts (E.T.), Disposition, Safety & Animal Research”, Sanofi, Vitry sur Seine, France (A.D), Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, New Jersey (R.A.I.), Departments of Drug Disposition, Development/ Commercialization, Eli Lilly and Co., Indianapolis, Indiana (A.D-M.), Drug Metabolism and Pharmacokinetics, Celgene Corp., Summit, New Jersey (P. S.), Drug Metabolism and Pharmacokinetics (DMPK), Bayer Pharma AG, Wuppertal, Germany (M.B.), Drug Metabolism and Pharmacokinetics, Takeda Pharmaceuticals International Co, Boston, Massachusetts (J.J.Y.), Bioanalytical Science and Toxicokinetics, Drug Metabolism and Pharmacokinetics, GlaxoSmithKline R&D, Ware, UK (M.B.), Preclinical Pharmacokinetics and In Vitro ADME, Biogen, Cambridge, Massachusetts (G.X.), Biologics Discovery DMPK and Bioanalytics Department, Merck Research Laboratories, Palo Alto, California (E.E.), Biologics Clinical Pharmacology, Janssen R&D, Spring House, Pennsylvania, (W.W.), Amgen Pharmacokinetics and Drug Metabolism (D.A.R.), Seattle Genetics Inc. (N.V.C), Department of Pharmaceutical Sciences, Roche Innovation Center, New York City, New York (D.J.M.) This article has not been copyedited and formatted. The final version may differ from this version. DMD Fast Forward. Published on December 15, 2015 as DOI: 10.1124/dmd.115.068049