Viral clearance using disposable systems in monoclonal antibody commercial downstream processing
✍ Scribed by Joe X. Zhou; Felix Solamo; Tony Hong; Michael Shearer; Tim Tressel
- Publisher
- John Wiley and Sons
- Year
- 2008
- Tongue
- English
- Weight
- 145 KB
- Volume
- 100
- Category
- Article
- ISSN
- 0006-3592
No coin nor oath required. For personal study only.
✦ Synopsis
Abstract
Once highly selective protein A affinity is chosen for robust mAb downstream processing, the major role of polishing steps is to remove product related impurities, trace amounts of host cell proteins, DNA/RNA, and potential viral contaminants. Disposable systems can act as powerful options either to replace or in addition to polishing column chromatography to ensure product purity and excellent viral clearance power for patients' safety. In this presentation, the implementation of three disposable systems such as depth filtration, membrane chromatography, and nanometer filtration technology in a commercial process are introduced. The data set of viral clearance with these systems is presented. Application advantages and disadvantages including cost analysis are further discussed. Biotechnol. Bioeng. 2008;100: 488–496. © 2008 Wiley Periodicals, Inc.