Research ArticleProceedings of the 2013 Viral Clearance Symposium
Session 4: Overall Integrated Viral Clearance and Adventitious Agents Strategy
Johannes Blümel and Omar Tounekti
PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 195-205; DOI: https://doi.org/10.5731/pdajpst.2015.01043
Johannes Blümel
1Paul-Ehrlich-Institut; and
Omar Tounekti
2Health Canada
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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 1
January/February 2015
Session 4: Overall Integrated Viral Clearance and Adventitious Agents Strategy
Johannes Blümel, Omar Tounekti
PDA Journal of Pharmaceutical Science and Technology Jan 2015, 69 (1) 195-205; DOI: 10.5731/pdajpst.2015.01043
Jump to section
- Article
- Background
- Streamlining Viral Filtration Studies Using a Single Model Virus (Eva Gefroh, Houman Dehghani, Megan McClure, Lisa Connell-Crowley, Ganesh Vedantham; Amgen)
- Can We Streamline Marketing Application–Level Chromatography Studies? Discussion of Used Resin, Column Cleaning, and Virus Distribution (Lisa Connell-Crowley, Amgen)
- CHO Retrovirus-Like Particle Stock Production for Use in Virus Clearance Studies (Rachel Specht, Genentech, Inc., a Member of the Roche Group)
- Evaluation of Virus Reduction by ‘Used’ Chromatography Resins—Interpretation of ICH Q5A (James Berrie, Principal Group Leader, Purification Development, Lonza)
- Toward Quantitative Adventitious Viral Risk Assessment (Paul Duncan, Merck, Sharp and Dohme)
- ICH Q5A—Time for An Update? (Søren Kamstrup, Novonordisk, A/S)
- ASTM Detergent Inactivation Standard (John Schreffler, Eisai)
- Platform Viral Clearance (Konstantin Zoeller, Novartis)
- Viral Clearance during Resin Lifetime of Protein A Affinity Chromatography and Anion-Exchange Chromatography (Hong Shen, Janssen Research & Development)
- Summary
- References
- Figures & Data
- References
- Info & Metrics
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