Abstract
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.
- Alternative detergents
- Low pH viral inactivation
- On-column viral inactivation
- Sugar-based surfactants
- Viral clearance
- Viral inactivation
- Received August 10, 2021.
- Accepted November 30, 2021.
- Copyright © 2021, Parenteral Drug Association
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