RT Journal Article
SR Electronic
T1 Proceedings of the 2023 Viral Clearance Symposium, Session 4: Continuous Processing
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 169
OP 175
DO 10.5731/pdajpst.2024.002244
VO 78
IS 2
A1 Fisher, John
A1 Lute, Scott
YR 2024
UL http://journal.pda.org/content/78/2/169.abstract
AB The continuous processing session at the 2023 Viral Clearance Symposium (VCS) focused on understanding how to effectively design viral clearance operations for use in continuous processes and methods to perform viral clearance studies. In this session, an approach to directly address control considerations with operating continuous-flow reactors for low pH viral inactivation was presented. Continuous-flow low pH incubation chamber design and implications for residence time determination were discussed. Additionally, viral clearance capability between batch operation and connected operation were demonstrated to be comparable for a connected bind-elute chromatography and flow-through chromatography step. Overall, this session provided additional scientific knowledge to support viral clearance strategies when implementing a continuous manufacturing process.