RT Journal Article
SR Electronic
T1 Proceedings of 2019 Viral Clearance Symposium, Session 5: Viral Inactivation
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2021.012681
DO 10.5731/pdajpst.2021.012681
A1 Junfen Ma
YR 2021
UL http://journal.pda.org/content/early/2021/12/16/pdajpst.2021.012681.abstract
AB Viral inactivation has been demonstrated to be an effective viral clearance step in the biologics purification processes. In the 2019 viral clearance symposium, the topics were focused on alternative eco-friendly and cost-effective detergents, validation of on-column viral inactivation and further understanding of low pH and solvent/detergent viral inactivation. Sugar-based surfactants and a synthetized replacement of Triton X-100 were evaluated to be effective and robust in inactivating enveloped viruses. For low pH viral inactivation, consistent pH measurement, through alignment of pH meters and probes across different labs and manufacturing facilities, was confirmed to be critical to ensure both product quality and safety. For the well-established solvent/detergent inactivation, an approach of adding pre-mixed solvent/detergent stock significantly improved operation. Different viral clearance approaches were discussed for on-column viral inactivation using a detergent-containing wash buffer.