RT Journal Article
SR Electronic
T1 Proceedings of the 2019 Viral Clearance Symposium, Session 8. Conference Summary: Key Discussion and Outcomes, Pending Questions, and Proposed Experiments and Actions
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 362
OP 367
DO 10.5731/pdajpst.2021.012684
VO 76
IS 4
A1 Glen Bolton
YR 2022
UL http://journal.pda.org/content/76/4/362.abstract
AB This report provides a high-level summary of the key outcomes and gaps based on the research presented at the 2019 Viral Clearance Symposium and identifies new areas for future study and improvements. The 2019 conference structure extended the framework from the preceding conferences, focusing on the key gaps and associated developments and including the additional focus areas of facility risk mitigation, modular viral clearance claims, depth filter viral clearance, retrospective analysis of viral clearance and continuous processing, quantitation and analysis of viral clearance, viral inactivation by detergents and low pH, viral filtration mechanisms, viral filtration of media, viral detection by next-generation sequencing, and ways to improve the efficiency of the overall adventitious agent strategy.