TY - JOUR T1 - Retrospective Evaluation of Low-pH Viral Inactivation and Viral Filtration Data from a Multiple Company Collaboration JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 293 LP - 299 DO - 10.5731/pdajpst.2016.006478 VL - 70 IS - 3 AU - John Mattila AU - Mike Clark AU - Shengjiang Liu AU - John Pieracci AU - Thomas R. Gervais AU - Eileen Wilson AU - Olga Galperina AU - Xinfang Li AU - David Roush AU - Konstantin Zoeller AU - Helene Brough AU - Christelle Simpson-Platre Y1 - 2016/05/01 UR - http://journal.pda.org/content/70/3/293.abstract N2 - 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. ER -