Retrospective Evaluation of Low-pH Viral Inactivation and Viral Filtration Data from a Multiple Company Collaboration

John Mattila; Mike Clark; Shengjiang Liu; John Pieracci; Thomas R. Gervais; Eileen Wilson; Olga Galperina; Xinfang Li; David Roush; Konstantin Zoeller; Helene Brough; Christelle Simpson-Platre

doi:10.5731/pdajpst.2016.006478

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.

Footnotes

DISCLAIMER: The following article is a special editorial contribution from the BioPhorum Operations Group (BPOG). Please note that it did not go through the PDA Journal of Pharmaceutical Science and Technology regular peer review process.

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