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PubMed
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- Published online February 17, 2015.
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© PDA, Inc. 2015
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- Article
- Background
- DoE-Based AEX Technology Comparison (George Miesegaes, CDER/FDA) [A larger body of this work has been published recently (1)]
- Viral Clearance for Vaccine Candidate Using Baculovirus Expression System Focusing On Aex Bind-Elute Chromatography (Adam Kristopeit, Merck, Sharp and Dohme, Inc.)
- Discussion
- Quantification of Retrovirus-Like Particle (RVLP) Removal at Manufacturing Scale (Christian H. Bell, Jutta Mayr, Marit Raible, Stefan Hepbildikler, Roche Diagnostics GmbH)
- Viral Clearance Strategy—General Considerations (Hannelore Willkommen, RBS-Consulting)
- Opportunities and Challenges of Working with a Human Cell Substrate (Dominick Vacante, Janssen Research & Development, LLC)
- Risk-Based Justification for Why Master Cell Bank (MCB) and Unprocessed Bulk (UPB) Are Screened by In Vitro Viral (IVV) Testing with Different Assay Durations (Dayue Chen, Eli Lilly)
- Design of Viral Clearance Study To Support Marketing Authorization (Olga Galperina, GSK)
- Summary
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