Technical / White Paper

Article on Viral Clearance for Biopharmaceuticals

Format: PDF file | Document type: Technical / White Paper | Promoted Content

This content is provided by Catalent, and any views and opinions expressed do not necessarily reflect those of

Article on Viral Clearance for Biopharmaceuticals

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 for a developmental phase-appropriate viral clearance package are detailed.

Learn more about:

Scale-down model qualification

Virus spike experiments

Validation (clearance evaluation) of manufacturing process

Latest content from Catalent

Related resources from Catalent

Show more

Supplier info centre