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Proceedings of the 2017 Viral Clearance Symposium

Stefan Hepbildikler1, Franz Nothelfer2

  • 1Roche Pharma Bioprocess Development, Nonnenwald 2, Penzberg 82377, Germany; and stefan.hepbildikler@roche.com.

PDA Journal of Pharmaceutical Science and Technology
|July 22, 2018
PubMed

Keywords:
Continuous processingDownstream processingFDAFacility risk mitigationHealth CanadaNovel format moleculesPEIRegulatory agenciesRegulatory perspectiveResin lifetimeStrategySubmissionUpstream processingViral Clearance SymposiumViral clearanceViral safety

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