Research ArticleProceedings of the 2017 Viral Clearance Symposium
Proceedings of the 2017 Viral Clearance Symposium, Session 4: Submission Strategies
Astrid Schwantes, Rachel Specht and Qi Chen
PDA Journal of Pharmaceutical Science and Technology September 2018, 72 (5) 498-510; DOI: https://doi.org/10.5731/pdajpst.2018.009142
Astrid Schwantes
1Virology Department, Paul-Ehrlich-Institut, Paul-Ehrlich-Strasse 51-59, 63225 Langen, Germany; and
Rachel Specht
2Process Virology, Genentech, 1 DNA Way South San Francisco, CA 94080, USA
Qi Chen
2Process Virology, Genentech, 1 DNA Way South San Francisco, CA 94080, USA

Reference
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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 5
September/October 2018
Proceedings of the 2017 Viral Clearance Symposium, Session 4: Submission Strategies
Astrid Schwantes, Rachel Specht, Qi Chen
PDA Journal of Pharmaceutical Science and Technology Sep 2018, 72 (5) 498-510; DOI: 10.5731/pdajpst.2018.009142
Jump to section
- Article
- Abstract
- Background and Session Overview
- Retrovirus Clearance Risk Evaluation and Clearance Target for Chinese Hamster Ovary Cells
- Bin Yang, Genentech
- A Proposal for Future BLA Submissions on Virus Filtration: Parvovirus Removal Studies Only
- Rachel Specht and Qi Chen, Genentech
- qPCR as an Alternative to TEM and Infectivity Assays
- William Rayfield, Merck
- The Use of RVLP in Research and Development Viral Clearance Studies
- Moritz Bennecke, Roche Pharma
- Getting Medicines to Patients Fast
- Sherrie Curtis, Genetech
- Streamlining Virus Clearance (VC) Studies to Reduce Costs and Time to Clinic
- Lisa Connell-Crowley, Just Biotherapeutics
- Viral Clearance Strategy for Early-Phase Program
- Mi Jin, Teva Pharmaceuticals
- ASTM Update on Standards for Low pH Inactivation and Virus Retentive Filtration
- John Schreffler, Janssen J&J
- Summary
- Conflict of Interest Declaration
- Reference
- Figures & Data
- References
- Info & Metrics
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