Research ArticleConference Proceeding
Session 4.2: Viral Spiking, Viral Preparation, and Upstream Risk Mitigation Strategies
Meisam Bakhshayeshi and Rachel Specht
PDA Journal of Pharmaceutical Science and Technology September 2016, 70 (5) 470-476; DOI: https://doi.org/10.5731/pdajpst.2016.006965
Meisam Bakhshayeshi
1Process Virology/Purification Development Department. Genentech, a Member of the Roche Group, 1 DNA Way, MS10, South San Francisco, CA 94080; and
Rachel Specht
2Senior Engineer, Biogen, 225 Binney Street, Cambridge, MA 02142

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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 5
September/October 2016
Session 4.2: Viral Spiking, Viral Preparation, and Upstream Risk Mitigation Strategies
Meisam Bakhshayeshi, Rachel Specht
PDA Journal of Pharmaceutical Science and Technology Sep 2016, 70 (5) 470-476; DOI: 10.5731/pdajpst.2016.006965
Jump to section
- Article
- Background
- (1) Virus Removal and Inactivation for Bispecific/Duobody® mAbs (Pedro Alfonso; Janssen Research & Development, LLC, Malvern, PA)
- (2) Ensuring Viral Safety of the Product with Inhomogeneous Feed Streams (Konstantin Zoeller; Novartis Pharma AG, Basel, Switzerland)
- (3) Impact of Viral Preparation Quality on VRF Performance (Dan LaCasse; Pfizer, Andover, MA)
- (4) Detection of Retroviral-like Particles Using Transmission Electron Microscopy (TEM) (Dominick Vacante; Janssen Research & Development, LLC, Malvern PA)
- (5) Media Virus Filtration (Thomas R. Kreil and Andreas Wieser; Baxalta, Vienna, Austria)
- (6) Next-Generation Sequencing (NGS) for Characterization of a Manufacturing Cell Bank (Thomas R. Kreil and Jens Modrof; Baxalta, Vienna, Austria)
- Conclusions
- References
- Figures & Data
- References
- Info & Metrics
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