Minute Virus of Mice (MVM) is a model parvovirus used commonly as an international regulatory standard for biopharmaceutical process validation. MockV™ non-infectious virus-like particles mimic the physicochemical properties of live infectious viruses used as spiking agents during clearance testing. The MockV MVM Kit contains stock solution of virus- like particles of Murine Virus of Mice (MVM) and all reagents for Immuno-QPCR analysis.
Dyer R, Song Y, Chen J, et al. Mechanistic insights into viral clearance during the chromatography steps in antibody processes by using virus surrogates. Biotechnol Progress. 2020;36:e3057. https://doi.org/10.1002/btpr.3057
Data from published manuscripts have shown that in the majority of parallel MVP vs. MVM experiments, LRV's of +/- 1.0 log10 are obtained. One caveat is that when complete clearance is achieved, an MVM LRV can be ≥ 5.0- 6.0 because of the low LOQ for TCID50 assays while the MVP LRV will be limited to ≥ 4.0-5.0 due to the higher LOQ for the Immuno-qPCR assay.
The Spiking MVP contained within the MockV MVM Kit is derived by recombinantly expressing the major capsid protein of live MVM. Besides the single MVM gene required to make this structural protein, no other MVM genetic elements are utilized during the process to make the MVP. Thus, even if MVM nucleic acid were to become incorporated into the assembled MVP, it would only contain the instructions to make the structural capsid protein. Plaque assay data demonstrating the non-infective nature of the particle can be provided upon request. Please contact [email protected].
Like live MVM, the Spiking MVP containing within the MockV MVM Kit is highly resistant to low pH inactivation techniques. LRV’s of ≤ 1.0 have been observed when utilized during such experiments.
The MockV MVM Kit comes with 1.5 mL’s of Spiking MVP. This is enough particle to challenge 10 loads of 150 mL’s each to a starting MVP concentration of 1.0 x 109 particles/mL. There are enough assay components for 3 x 96 well reactions. Additional Spiking MVP and individual assay components can be purchased.
For most chromatography experiments, it is recommended to target a spiked load concentration of 1.0 x 109 – 1.0 x 1010. For nanofiltration experiments a total particle challenge of ≤ 11.0 log10 per small scale device could be first attempted. If flux decay does not become a factor, follow-up experiments could target higher total particle challenges.