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

학술저널

issue
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.
Author
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.
DB Label
Database : MEDLINE
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