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 to 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, and the more traditional low pH or (solvent-) detergent treatments are used widely, 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.
LAY ABSTRACT: To enhance virus clearance capacity, manufacturing processes of therapeutic proteins include process steps dedicated to virus clearance, especially virus-retentive filtration and virus inactivation. This article summarizes the current understanding of process preferences for the said process steps.
- Downstream processing
- Virus-retentive filtration
- Virus inactivation
- Low pH treatment
- Detergent treatment
- © PDA, Inc. 2018
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Jump to section
- Article
- Abstract
- Introduction
- Optimization of Viral Filtration Process Conditions to Enable a Representative Scale-Down Model
- Virus Filtration—challenges for Scale-Down
- Effects of Pressure Source on Virus Breakthrough During Viral Filtration
- Multiple, Deliberate Interruptions of a Virus Removal Filtration Process—Impact on Virus Retention and Throughput
- Validating an Alternative Virus Reduction Filter for a Commercial Product
- Investigational Study on the Robustness of the 20-nm Nanofiltration Step Performed According to the Doe Methodology
- What to Do When the Virus Filtration Cannot Be Validated as Usual?
- Establishing a Generic Claim for Lauryldimethylamine N-oxide Detergent Inactivation
- Virus Inactivation at Low pH: Impact of Buffer Composition, pH Value, and Protein Concentration on the Inactivation of Different Retroviruses
- Conclusion
- Conflict of Interest Declaration
- Reference
- Figures & Data
- References
- Info & Metrics
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- Proceedings of the 2019 Viral Clearance Symposium, Session 4: Viral Clearance Strategy and Process Understanding