MockV® MVM Kit

Viral contamination is an inherent risk during the manufacture of therapeutic products such as antibodies, vaccines, and plasma derivates. To ensure safety, regulatory agencies 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 traditionally assessed in specialized Biological Safety Level laboratories (BSL2 or above), via small-scale “spiking studies”, whereby live model mammalian virus (ex. Minute Virus of Mice, or MVM) is introduced into in-process material and subjected to processing/ purification (e.g. 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.  MockV^® non-infectious virus-like particles mimic the physicochemical properties of live infectious viruses used as spiking agents during clearance testing, thus reducing the need and/or frequency of live spiking studies. MockV kits enable benchtop scientists to easily and economically quantify viral clearance in industrial processes. Each BSL-1 compatible MVM kit contains the necessary reagents to conduct mock virus particle spiking experiments, including a concentrated and purified stock solution of MVP and quantification reagents.