The process capability and potential for various forms of chromatography to remove viruses
have been discussed extensively in the literature, including the observed variability in …

The session provided an update on the application and mechanistic understanding of
intensified unit operations (eg, mixed mode depth filters, mixed mode AEX) since the last …

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 …

Anion exchange chromatography (AEX) operated under weak partitioning mode has been
proven to be a powerful polishing step as well as a robust viral clearance step in Pfizer's …

The manufacturing processes of biological medicinal products are expected to be capable of
removing and/or inactivating viruses, to primarily provide for adequate safety margins to …

We evaluated viral clearance in multiply-cycled anion-exchange media run in flow-through
mode. We found that anion-exchange columns do not lose viral clearance capacity after …

The successful implementation of any biologically derived product in human clinical trials
and as a marketed biopharmaceutical requires the critical utilization of effective viral …

Multicolumn capture chromatography is gaining increased attention lately due to the
significant economic and process advantages it offers compared with traditional batch mode …

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 …

The potential of viral contamination is a regulatory concern for continuous cell line‐derived
pharmaceutical proteins. Complementary and redundant safety steps, including an …