title: Retrospective Evaluation of Low-pH Viral Inactivation and Viral Filtration Data from a Multiple Company Collaboration.
abstract: 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.
authors.affiliation: Regeneron Pharmaceuticals, Inc., Tarrytown, NY; John.Mattila@regeneron.com.
authors.forename: John
authors.initials: J
authors.lastname: Mattila
authors.affiliation: AbbVie, Inc., Worcester, MA;
authors.forename: Mike
authors.initials: M
authors.lastname: Clark
authors.affiliation: Bayer Corporation, Berkeley, CA;
authors.forename: Shengjiang
authors.initials: S
authors.lastname: Liu
authors.affiliation: Biogen, Cambridge, MA;
authors.forename: John
authors.initials: J
authors.lastname: Pieracci
authors.affiliation: Bristol-Myers Squibb, East Syracuse, NY;
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Gervais
authors.affiliation: GlaxoSmithKline plc, King of Prussia, PA;
authors.forename: Eileen
authors.initials: E
authors.lastname: Wilson
authors.affiliation: GlaxoSmithKline plc, Rockville, MD;
authors.forename: Olga
authors.initials: O
authors.lastname: Galperina
authors.affiliation: ImmunoGen, Inc., Waltham, MA;
authors.forename: Xinfang
authors.initials: X
authors.lastname: Li
authors.affiliation: Merck, Sharp and Dohme, Inc., Kenilworth, NJ;
authors.forename: David
authors.initials: D
authors.lastname: Roush
authors.affiliation: Novartis Pharma AG, Basel, Switzerland;
authors.forename: Konstantin
authors.initials: K
authors.lastname: Zoeller
authors.affiliation: Shire plc., Pepperell, MA; and.
authors.forename: Helene
authors.initials: H
authors.lastname: Brough
authors.affiliation: Biophorum Operations Group, Sheffield, UK.
authors.forename: Christelle
authors.initials: C
authors.lastname: Simpson-Platre
mesh_terms: D001709:Biotechnology / Q000592:standards* / Q000706:statistics & numerical data; D003299:Cooperative Behavior; D016208:Databases, Factual / Q000592:standards* / Q000706:statistics & numerical data; D004340:Drug Contamination / Q000517:prevention & control; D005374:Filtration / Q000592:standards; D006564:Herpesviridae; D006801:Humans; D006863:Hydrogen-Ion Concentration; D012189:Retrospective Studies; D012190:Retroviridae; D011795:Surveys and Questionnaires; D038301:Virus Inactivation