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- Published online October 6, 2018.
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- previous version (July 20, 2018 - 14:19).
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© PDA, Inc. 2018
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- 1Roche Pharma Bioprocess Development, Nonnenwald 2, 82377 Penzberg, Germany;
- 2Center for Drug Evaluation and Research, Office of Biotechnology Products, U.S. Food and Drug Administration; and
- 3Paul-Ehrlich-Institut, Virology Department, Paul-Ehrlich-Strasse 51-59, 63225 Langen, Germany
- ↵* Corresponding Author: Roche Pharma Bioprocess Development, Penzberg, Germany. E-mail: stefan.hepbildikler{at}roche.com
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- Article
- Abstract
- Introduction
- Session 1.1: Upstream Mitigation—Cell Bank and Bulk Harvest Testing
- Session 1.2: Upstream Risk Mitigation—Virus Barrier Filter and High-temperature Short-Time Treatment
- Session 2.1: Downstream Unit Operations—Virus Filtration/Inactivation
- Session 2.2: Downstream Unit Operations—Purification Unit Operations
- Session 3: Resin Lifetime
- Session 4: Submission Strategies
- Session 5: Facility Risk Mitigation
- Session 6: Continuous Processing
- Disclaimer
- Conflict of Interest Declaration
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