Research ArticleConference Proceeding
Session 4.1: Case Studies of Application of Generic Claims and QbD for Viral Clearance
Rachel Specht and Meisam Bakhshayeshi
PDA Journal of Pharmaceutical Science and Technology September 2016, 70 (5) 462-469; DOI: https://doi.org/10.5731/pdajpst.2016.006957
Rachel Specht
1Process Virology/Purification Development Department. Genentech, a Member of the Roche Group, 1 DNA Way, MS10, South San Francisco, CA 94080; (650) 467-2372; ; and
Meisam Bakhshayeshi
2Senior Engineer, Biogen, 225 Binney Street, Cambridge, MA 02142; (617) 679-3264;
References
- 1.↵Proceedings of the 2009 Viral Clearance Symposium. Karger, 2010.
- 2.↵
- Stuckey J.,
- Strauss D.,
- Venkiteshwaran A.,
- Gao J.,
- Luo W.,
- Quertinmont M.,
- O'Donnell S.,
- Chen D.
- 3.↵Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use, 1997.
- 4.↵ASTM Standard E2888. Standard Practice for Inactivation of Rodent Retrovirus by pH, 2012.
- 5.↵PDA Technical Report No. 41.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 5
September/October 2016
Session 4.1: Case Studies of Application of Generic Claims and QbD for Viral Clearance
Rachel Specht, Meisam Bakhshayeshi
PDA Journal of Pharmaceutical Science and Technology Sep 2016, 70 (5) 462-469; DOI: 10.5731/pdajpst.2016.006957
Jump to section
- Article
- Introduction
- (1) Implementation of Modular Claims for the Clearance of Xenotropic Murine Leukemia Virus (XMuLV) by Low-pH Inactivation and Virus-Retentive Filtration (Michael Clark, AbbVie Bioresearch Center, Worcester, MA)
- Low-pH Inactivation
- Virus-Retentive Filtration
- (2) The Use of Viresolve Pro in a Modular Viral Clearance Process (Dan LaCasse; Pfizer, Andover, MA)
- (3) ASTM and the Development of Standards for Virus Removal and/or Inactivation (Bob Steininger)
- (4) Virus Filtration QbD (Rachel Specht; Genentech, South San Francisco, CA)
- (5) Viral Safety Considerations in Dual Sourcing of Raw Materials in Downstream Processing (Stefan Hepbildikler; Roche, Penzberg, Germany)
- Summary
- References
- Figures & Data
- References
- Info & Metrics
Related Articles
- No related articles found.
Cited By...
- No citing articles found.