Viral Clearance in Biomanufacturing

Viral contamination is an inherent risk during the manufacture of therapeutic products such as antibodies, vaccines, and plasma derivates. Whether introduced endogenously from raw materials or exogenously through manufacturing operations, unmitigated viral contaminations have led to serious health implications and plant shut downs.  International regulatory agencies therefore require sponsoring companies to validate the “viral clearance efficacy” of their individual downstream purification process steps prior to clinical trials or commercial approval. 

Viral clearance validation is assessed through small scale “spiking studies” whereby model mammalian virus (ex. Minute Virus of Mice) is introduced into in-process material which is then processed through a purification technique (ex. chromatography, nanofiltration, low pH, etc.). Viral quantity pre/post processing is determined through an infectivity (ex. TCID50) or qPCR assay and Log Reduction Value is calculated.  These studies require specialized Biological Safety Level laboratories (BSL) and experienced personnel.

 

Useful references