Anti-drug Antibody Sample Testing and Reporting Harmonization.

Autor: Jani D; Bioanalytical and Molecular Assays, Moderna, Cambridge, Massachusetts, USA. Darshana.jani@modernatx.com., Marsden R; Revelation Biosciences, California, USA., Gunsior M; Research and Translational Sciences, Astria Therapeutics, Boston, Massachusetts, USA., Hay LS; Bioanalytical Lab, PPD Clinical Research Services, Thermo Fisher Scientific, Richmond, Virginia, USA., Ward B; Bioanalytical Lab, PPD Clinical Research Services, Thermo Fisher Scientific, Richmond, Virginia, USA., Cowan KJ; New Biological Entities Drug Metabolism and Pharmacokinetics, Merck KGaA, Darmstadt, Germany., Azadeh M; Biomarker Operations, Translational Medicine and Early Stage Clinical Development, Alkermes, Inc., Waltham, Massachusetts, USA., Barker B; Drug Metabolism and Biopharmaceuticals, Incyte Corporation, Wilmington, Delaware, USA., Cao L; Biomarker and BioAnalytical Sciences, Sangamo Therapeutics, California, USA., Closson KR; Laboratory Operations, Immunologix Laboratories, Tampa, Florida, USA., Coble K; DMPK/Bioanalytical Sciences, Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Connecticut, USA., Dholakiya SL; Non-Clinical Disposition and Bioanalysis, Bristol Myers Squibb, Princeton, New Jersey, USA., Dusseault J; Laboratory Sciences, Charles River Laboratories, Quebec, Canada., Hays A; BioAgilytix, Durham, North Carolina, USA., Herl C; Clinical Pharmacology and Translational Sciences, Exelixis, Alameda, California, USA., Hodsdon ME; Laboratory for Experimental Medicine, Eli Lilly and Company, Indianapolis, Indiana, USA., Irvin SC; Bioanalytical Sciences, Regeneron Pharmaceuticals, Tarrytown, New York, USA., Kirshner S; Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drugs Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Kolaitis G; Non-Clinical Disposition and Bioanalysis, Bristol Myers Squibb, Princeton, New Jersey, USA., Kulagina N; Pharmaceutical Development Services, Smithers, Gaithersburg, Maryland, USA., Kumar S; EMD Serono Research and Development Institute (A business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA., Lai CH; Bioanalytical Sciences, Regeneron Pharmaceuticals, Tarrytown, New York, USA., Lipari F; Nexelis, a Q2 Solutions Company, Vaccine Sciences, Laval, Quebec, Canada., Liu S; Global Product Development, Clinical Assay Group, Pfizer Inc., Kirkland, Quebec, Canada., Merdek KD; Biomarkers and Clinical Bioanalyses (TMED), Sanofi, Framingham, Massachusetts, USA., Moldovan IR; Cellular Technology Limited (CTL), Shaker Heights, Ohio, USA., Mozaffari R; Bioanalysis, Immunogenicity and Biomarkers (BIB), IVIVT, Research, GSK, Collegeville, Pennsylvania, USA., Pan L; Clinical Biomarker Innovation and Development, Takeda Development Center Americas Inc., Cambridge, Massachusetts, USA., Place C; DMPK/Bioanalytical Sciences, Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Connecticut, USA., Snoeck V; Translational Biomarkers and Bioanalysis, UCB Biopharma SRL, Braine-l'Alleud, Belgium., Manning MS; Translational Safety and Bioanalytical Sciences, Amgen Inc., Thousand Oaks, California, USA., Stocker D; Non-Clinical Disposition and Bioanalysis, Bristol Myers Squibb, Princeton, New Jersey, USA., Tary-Lehmann M; Cellular Technology Limited, Department Contract Laboratory, Shaker Heights, Ohio, USA., Turner A; Pharmaceutical Development Services, Smithers, Gaithersburg, Maryland, USA., Vainshtein I; Clinical Pharmacology and Translational Sciences, Exelixis, Alameda, California, USA., Verthelyi D; Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drugs Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Williams WT; Bioanalytical Operations, BioAgilytix Labs, Durham, North Carolina, USA., Yan H; Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drugs Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Yan W; Department of Bioanalytical Sciences, Genentech, South San Francisco, California, USA., Yang L; Clinical Biomarker Innovation and Development, Takeda Development Center Americas Inc., Cambridge, Massachusetts, USA., Yang L; Bioanalytical Sciences, REGENXBIO Inc., Rockville, Maryland, USA., Zemo J; Bioanalytical Operations, BioAgilytix Labs, Durham, North Carolina, USA., Zhong ZD; Development Sciences, Denali Therapeutics, South San Francisco, California, USA.

Publikováno v: The AAPS journal [AAPS J] 2022 Oct 28; Vol. 24 (6), pp. 113. Date of Electronic Publication: 2022 Oct 28.