Proceedings of the 2017 Viral Clearance Symposium.

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作者： Stefan,Hepbildikler ^[1] ; Franz,Nothelfer ^[2]

作者单位： Roche Pharma Bioprocess Development, Nonnenwald 2, Penzberg 82377, Germany; and stefan.hepbildikler@roche.com. ^[1] Boehringer Ingelheim, Birkendorfer Str. 65, Biberach an der Riß 88397, Germany. ^[2]

关键词 Continuous processing Downstream processing FDA Facility risk mitigation Health Canada Novel format molecules PEI Regulatory agencies Regulatory perspective Resin lifetime Strategy Submission Upstream processing Viral Clearance Symposium Viral clearance Viral safety

主题词人类(Humans);工业(Industry);蛋白质类(Proteins);工艺学, 制药(Technology, Pharmaceutical);病毒灭活(Virus Inactivation);病毒(Viruses)

DOI 10.5731/pdajpst.2018.009076

PMID 30030350

发布时间 2019-05-29

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PDA journal of pharmaceutical science and technology

453-454页

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Proceedings of the 2017 Viral Clearance Symposium.

PDA journal of pharmaceutical science and technology

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PDA journal of pharmaceutical science and technology

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Proceedings of the 2017 Viral Clearance Symposium.

PDA journal of pharmaceutical science and technology

相似文献

PDA journal of pharmaceutical science and technology

相关期刊

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