PT  - JOURNAL ARTICLE
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
TI  - Retrospective Evaluation of Low-pH Viral Inactivation and Viral Filtration Data from a Multiple Company Collaboration
AID  - 10.5731/pdajpst.2016.006478
DP  - 2016 May 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 293--299
VI  - 70
IP  - 3
4099  - http://journal.pda.org/content/70/3/293.short
4100  - http://journal.pda.org/content/70/3/293.full
SO  - PDA J Pharm Sci Technol2016 May 01; 70
AB  - 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.