RT Journal Article
SR Electronic
T1 Proceedings of the 2019 Viral Clearance Symposium, Session 2: New Modalities in Chromatography and Adsorptive Filters
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 306
OP 314
DO 10.5731/pdajpst.2021.012678
VO 76
IS 4
A1 Rachel Specht
A1 Astrid Schwantes
YR 2022
UL http://journal.pda.org/content/76/4/306.abstract
AB In Session 2 of the 2019 Viral Clearance Symposium, new outcomes of viral clearance performance of polishing chromatography and depth filters utilized in the purification processes of biotechnologically produced recombinant proteins such as monoclonal antibodies were presented. It was shown that flow through both multimodal anion-exchange and anion-exchange chromatography are effective tools for removal of retroviruses and, under defined conditions, also for parvoviruses. Cation-exchange chromatography, when operated in bind/elute mode, hydrophobic interaction chromatography, and depth filtration can also be potent for virus removal, but are less robust for parvoviruses. Despite these data provide further understanding of virus removal mechanisms by chromatography and depth filtration operations, more investigation is required for a clear understanding of the molecular mechanisms of virus removal and the relevance of different moleculés interactions including resin, virus, and product.