RT Journal Article
SR Electronic
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
FD Parenteral Drug Association (PDA)
SP 293
OP 299
DO 10.5731/pdajpst.2016.006478
VO 70
IS 3
A1 Mattila, John
A1 Clark, Mike
A1 Liu, Shengjiang
A1 Pieracci, John
A1 Gervais, Thomas R.
A1 Wilson, Eileen
A1 Galperina, Olga
A1 Li, Xinfang
A1 Roush, David
A1 Zoeller, Konstantin
A1 Brough, Helene
A1 Simpson-Platre, Christelle
YR 2016
UL http://journal.pda.org/content/70/3/293.abstract
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.