Abstract
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 for patients and to thus satisfy the corresponding regulatory expectations. To achieve this goal, process segments specifically dedicated to the task of virus removal or inactivation are designed into manufacturing flows. The State-of-the-Art now includes virus removal by nanofiltration, but also the more traditional low pH or (solvent-) detergent treatments are widely in use, often to provide for two complementary and mechanically different means of virus clearance. Reflective of these process preferences, the Virus Filtration / Inactivation session included seven case studies on virus filtration, and one each for a detergent and a low pH treatment.
- Detergent treatment
- Downstream processing
- Low pH treatment
- Viral Clearance
- Virus-retentive filtration
- Virusinactivation
- Received June 18, 2018.
- Accepted June 28, 2018.
- Copyright © 2018, Parenteral Drug Association
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