Viral contamination in biologic manufacture and implications for emerging therapies.

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作者： Paul W,Barone ^[1] ; Michael E,Wiebe ^[1] ; James C,Leung ^[1] ; Islam T M,Hussein ^[1] ; Flora J,Keumurian ^[1] ; James,Bouressa ^[2] ; Audrey,Brussel ^[3] ; Dayue,Chen ^[4] ; Ming,Chong ^[5] ; Houman,Dehghani ^[6] ; Lionel,Gerentes ^[7] ; James,Gilbert ^[8] ; Dan,Gold ^[9] ; Robert,Kiss ^[10] ; Thomas R,Kreil ^[11] ; René,Labatut ^[12] ; Yuling,Li ^[13] ; Jürgen,Müllberg ^[14] ; Laurent,Mallet ^[7] ; Christian,Menzel ^[15] ; Mark,Moody ^[16] ; Serge,Monpoeho ^[4] ; Marie,Murphy ^[17] ; Mark,Plavsic ^[18] ; Nathan J,Roth ^[19] ; David,Roush ^[11] ; Michael,Ruffing ^[20] ; Richard,Schicho ^[21] ; Richard,Snyder ^[22] ; Daniel,Stark ^[23] ; Chun,Zhang ^[24] ; Jacqueline,Wolfrum ^[6] ; Anthony J,Sinskey ^[25] ; Stacy L,Springs ^[26]

作者单位： Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA, USA. ^[1] Pfizer Inc., Andover, MA, USA. ^[2] Retired, Andover, MA, USA. ^[3] Sanofi, Paris, France. ^[4] LFB, Les Ulis, France. ^[5] Eli Lilly, Indianapolis, IN, USA. ^[6] Genentech, South San Francisco, CA, USA. ^[7] CSL Behring, Melbourne, Victoria, Australia. ^[8] Amgen, Thousand Oaks, CA, USA. ^[9] Allogene Therapeutics, South San Francisco, CA, USA. ^[10] Sanofi Pasteur, Marcy L'Étoile, France. ^[11] Biogen Inc., Cambridge, MA, USA. ^[12] Independent consultant, Westcliffe, CO, USA. ^[13] BioMarin, San Raphael, CA, USA. ^[14] Sutro Biopharma Inc., South San Francisco, CA, USA. ^[15] Baxter/Baxalta/Shire, now part of Takeda, Vienna, Austria. ^[16] MedImmune, Gaithersburg, MD, USA. ^[17] Innoforce, Hangzhou, Zhejiang, China. ^[18] Bristol-Myers Squibb, Devens, MA, USA. ^[19] EDQM, Strasbourg, France. ^[20] Merck Group, Geneva, Switzerland. ^[21] Merrimack Pharmaceuticals, Cambridge, MA, USA. ^[22] Immunova, Cambridge, MA, USA. ^[23] Regeneron, Rensselaer, NY, USA. ^[24] Sanofi Genzyme, Cambridge, MA, USA. ^[25] Lysogene, Cambridge, MA, USA. ^[26] CSL Behring, Bern, Switzerland. ^[27] Merck & Co., Inc., Kenilworth, NJ, USA. ^[28] Boehringer Ingelheim, Biberach, Germany. ^[29] Bristol-Myers Squibb, New York, NY, USA. ^[30] Shire, Atlanta, GA, USA. ^[31] Brammer Bio, Alachua, FL, USA. ^[32] Novartis, Basel, Switzerland. ^[33] Shire, Lexington, MA, USA. ^[34] Evelo Biosciences, Cambridge, MA, USA. ^[35] Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA, USA. ssprings@mit.edu. ^[36]