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Anti-drug Antibody Sample Testing and Reporting Harmonization.

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作者单位: Bioanalytical and Molecular Assays, Moderna, Cambridge, Massachusetts, USA. Darshana.jani@modernatx.com. [1] Revelation Biosciences, California, USA. [2] Research and Translational Sciences, Astria Therapeutics, Boston, Massachusetts, USA. [3] Bioanalytical Lab, PPD Clinical Research Services, Thermo Fisher Scientific, Richmond, Virginia, USA. [4] New Biological Entities Drug Metabolism and Pharmacokinetics, Merck KGaA, Darmstadt, Germany. [5] Biomarker Operations, Translational Medicine and Early Stage Clinical Development, Alkermes, Inc., Waltham, Massachusetts, USA. [6] Drug Metabolism and Biopharmaceuticals, Incyte Corporation, Wilmington, Delaware, USA. [7] Biomarker and BioAnalytical Sciences, Sangamo Therapeutics, California, USA. [8] Laboratory Operations, Immunologix Laboratories, Tampa, Florida, USA. [9] DMPK/Bioanalytical Sciences, Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Connecticut, USA. [10] Non-Clinical Disposition and Bioanalysis, Bristol Myers Squibb, Princeton, New Jersey, USA. [11] Laboratory Sciences, Charles River Laboratories, Quebec, Canada. [12] BioAgilytix, Durham, North Carolina, USA. [13] Clinical Pharmacology and Translational Sciences, Exelixis, Alameda, California, USA. [14] Laboratory for Experimental Medicine, Eli Lilly and Company, Indianapolis, Indiana, USA. [15] Bioanalytical Sciences, Regeneron Pharmaceuticals, Tarrytown, New York, USA. [16] Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drugs Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA. [17] Pharmaceutical Development Services, Smithers, Gaithersburg, Maryland, USA. [18] EMD Serono Research and Development Institute (A business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA. [19] Nexelis, a Q2 Solutions Company, Vaccine Sciences, Laval, Quebec, Canada. [20] Global Product Development, Clinical Assay Group, Pfizer Inc., Kirkland, Quebec, Canada. [21] Biomarkers and Clinical Bioanalyses (TMED), Sanofi, Framingham, Massachusetts, USA. [22] Cellular Technology Limited (CTL), Shaker Heights, Ohio, USA. [23] Bioanalysis, Immunogenicity and Biomarkers (BIB), IVIVT, Research, GSK, Collegeville, Pennsylvania, USA. [24] Clinical Biomarker Innovation and Development, Takeda Development Center Americas Inc., Cambridge, Massachusetts, USA. [25] Translational Biomarkers and Bioanalysis, UCB Biopharma SRL, Braine-l'Alleud, Belgium. [26] Translational Safety and Bioanalytical Sciences, Amgen Inc., Thousand Oaks, California, USA. [27] Cellular Technology Limited, Department Contract Laboratory, Shaker Heights, Ohio, USA. [28] Bioanalytical Operations, BioAgilytix Labs, Durham, North Carolina, USA. [29] Department of Bioanalytical Sciences, Genentech, South San Francisco, California, USA. [30] Bioanalytical Sciences, REGENXBIO Inc., Rockville, Maryland, USA. [31] Development Sciences, Denali Therapeutics, South San Francisco, California, USA. [32]
DOI 10.1208/s12248-022-00762-6
PMID 36307592
发布时间 2023-01-17
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