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MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility.

Autor: Koenigsberg AL; Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA., Fowler V; Oxford Nanopore Technologies, Oxford, United Kingdom., Domike R; Light Pharma, Cambridge, MA.; Manufacturing Engineering at Brigham Young University, Provo, UT., Brussel A; PathoQuest, Paris, France., Barone PW; Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA., Keumurian FJ; Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA., Leung J; Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA., Wiebe ME; Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA., Brewer MT; ThermoFisher, Waltham, MA., Chan S; Gritstone, Emeryville, CA., Dumey N; Sanofi, Marcy L'Étoile, France., Fournillier A; Sanofi, Marcy L'Étoile, France., Goodnight M; AstraZeneca, Gaithersburg, MD., Kindermann J; Takeda, Vienna, Austria., Leavy R; Amgen, Thousand Oaks, CA., Lee B; Genentech, South San Francisco, CA., Minning S; Boehringer Ingelheim, Biberach, Germany., Murphy M; Eli Lilly, Dublin, Ireland., Myers E; Pfizer, Andover, MA., Nahabedian A; Pfizer, Andover, MA., Nanda K; Biogen, Durham, NC., Parriott S; BioMarin, San Rafael, CA., Raju GK; Light Pharma, Cambridge, MA., Scallan C; Gritstone, Emeryville, CA., Schoch S; CSL Behring, Marburg, Germany., Shiminsky J; BMS, Devens, MA., Shum B; Genentech, South San Francisco, CA., Teitz S; Asahi Kasei, Cologne, Germany; and., Westrek B; Merck & Co. Inc., Kenilworth, NJ., Springs SL; Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA; ssprings@mit.edu.

Publikováno v: PDA journal of pharmaceutical science and technology [PDA J Pharm Sci Technol] 2023 Mar-Apr; Vol. 77 (2), pp. 115-132. Date of Electronic Publication: 2022 Oct 14.