Retrospective Evaluation of Low-pH Viral Inactivation and Viral Filtration Data from a Multiple Company Collaboration.
| Autor: | Mattila J; Regeneron Pharmaceuticals, Inc., Tarrytown, NY; John.Mattila@regeneron.com., Clark M; AbbVie, Inc., Worcester, MA;, Liu S; Bayer Corporation, Berkeley, CA;, Pieracci J; Biogen, Cambridge, MA;, Gervais TR; Bristol-Myers Squibb, East Syracuse, NY;, Wilson E; GlaxoSmithKline plc, King of Prussia, PA;, Galperina O; GlaxoSmithKline plc, Rockville, MD;, Li X; ImmunoGen, Inc., Waltham, MA;, Roush D; Merck, Sharp and Dohme, Inc., Kenilworth, NJ;, Zoeller K; Novartis Pharma AG, Basel, Switzerland;, Brough H; Shire plc., Pepperell, MA; and., Simpson-Platre C; Biophorum Operations Group, Sheffield, UK. |
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| Jazyk: | angličtina |
| Zdroj: | PDA journal of pharmaceutical science and technology [PDA J Pharm Sci Technol] 2016 May-Jun; Vol. 70 (3), pp. 293-9. Date of Electronic Publication: 2016 Mar 28. |
| DOI: | 10.5731/pdajpst.2016.006478 |
| Abstrakt: | Considerable resources are spent within the biopharmaceutical industry to perform viral clearance studies, which are conducted for widely used unit operations that are known to have robust and effective retrovirus clearance capability. The collaborative analysis from the members of the BioPhorum Development Group Viral Clearance Working Team considers two common virus reduction steps in biopharmaceutical processes: low-pH viral inactivation and viral filtration. Analysis included eight parameters for viral inactivation and nine for viral filtration. The extensive data set presented in this paper provides the industry with a reference point for establishing robust processes in addition to other protocols available in the literature (e.g., ASTM Std. E2888-12 for low-pH inactivation). In addition, it identifies points of weakness in the existing data set and instructs the design and interpretation of future studies. Included is an abundance of data that would have been difficult to generate individually but collectively will help support modular viral clearance claims. (© PDA, Inc. 2016.) |
| Databáze: | MEDLINE |
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