Viral clearance for biopharmaceutical downstream processes
نویسندگان
چکیده
2015 Viral clearance studies are mandated prior to entering clinical trials and for commercial launch of biopharmaceuticals. These studies are a key component of risk mitigation to reduce the potential for iatrogenic transmission of pathogenic viruses. This paper reviews regulatory guidance and practical strategies for designing viral clearance studies. Essential elements of a developmental phase-appropriate viral clearance package are detailed. These include scale-down model qualification, virus spike experiments and validation (clearance evaluation) of manufacturing process steps. Heuristics and learnings from available data are shared. Developments in this area including generic validation strategies, multiviral spiking strategies and use of newer model viruses for nonconventional substrates are also described. This review provides a framework for a comprehensive viral validation package for regulatory submissions.
منابع مشابه
Biopharmaceutical Process Evaluated for Viral Clearance
© 2009 Microbac Laboratories, Inc. Page 1 of 7 The purpose of Viral Clearance evaluation is to assess the capability of a manufacturing production process to inactivate and/or remove potential viral contaminants. Experience and knowledge in selecting the most relevant target viruses, appropriate purification steps, and viral clearing agents are critical in the design and implementation of a cos...
متن کاملViral Safety and Evaluation of Viral Clearance from Biopharmaceutical Products. Proceedings of a meeting. Bethesda, Maryland, USA, June 14-16, 1995.
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