MockV Solutions Announces Collaboration with NIH for Predicting Viral Clearance During Small Scale Bioprocess Development

Rockville, MD – May 14, 2018 – MockV Solutions, Inc. (MockV or the Company), a company developing innovative products to analyze virus clearance during process development, announced today that it will be collaborating with the Vaccine Production Program of the Vaccine Research Center/National Institute of Allergy and Infectious Diseases/National Institutes of Health (VRC, NIAID, NIH) to evaluate its lead product candidate, the MVM-MVP Kit. The MVM-MVP Kit contains a non-infectious “Mock Virus Particle” (MVP) spiking surrogate that mimics the physicochemical characteristics of Minute Virus of Mice (MVM), a small and physiochemically resistant parvovirus, used as a universal standard for assessing viral clearance during process validation studies. The intention of this collaboration is to determine if the non-infectious MVP could be used as an accurate and economic indicator of MVM clearance during small scale bioprocess development studies.

Currently, viral clearance assessments are made by propagated and spiking live infectious viruses, such as MVM, into biopharmaceutical material. This spiked material is then processed through a scale down version of a bio-separation process step. Quantification of virus is analyzed for samples taken before and after processing to determine clearance. Because of the reliance on infectious virus, these studies are costly, time consuming and require specialized facilities. MockV’s MVM-MVP Kit is designed to alleviate these challenges and enable process development scientist to efficiently optimize robust manufacturing processes ahead of viral clearance regulatory studies.

“We look forward to collaborating with the VRC, NIAID, NIH as we advance our lead product toward commercialization,” stated David Cetlin M.S. Chief Executive Officer of MockV. “MockV believes that the MVM-MVP Kit has the potential to address the current challenges and shortcomings of viral clearance as it relates to process development and optimization. We are excited to move forward with this collaboration

About the Vaccine Production Program

The Vaccine Production Program (VPP) within the VRC, NIAID, NIH is responsible for translating candidate research vaccines into materials for proof-of-concept clinical trials and to enable advanced development and licensure by partners. The VPP is responsible for process design/development, analytical characterization, current good manufacturing practices (cGMP) manufacturing, and pre-clinical safety testing for all VRC products. Since its inception in 2001, the VPP has overseen the manufacture of over 80 bulk pharmaceutical compounds formulated into over 45 different vaccine and therapeutic products. These products include candidate vaccines for HIV, influenza, chikungunya, SARS, West Nile, Zika, and filoviruses including Ebola and Marburg.

About MockV, Inc.

MockV Solutions, Inc. (MVS) is a biotechnology company commercializing non-infectious viral-surrogate tools to a variety of industries that currently rely on expensive and logistically challenging live virus analysis. MockV is developing a novel series of analytical assay kits which will enable biopharmaceutical process development scientists to study the efficacy of manufacturing techniques intended to remove or inactive virus, a contaminant of great concern during the manufacturing of biopharmaceuticals. These products are only approved for clinical or commercial use after their manufacturing processes demonstrate sufficient viral clearance. Currently, this is accomplished through the use of live mammalian model viruses (ex. MVM and XMuLV) in expensive and logistically challenging “spiking studies”. The lack of economical and accurate means of analyzing viral clearance during small scale process development increases the risk of failing viral clearance regulatory requirements – jeopardizing the timely approval of potentially life-altering therapies. MockV’s lead product candidate, the MVM-MVP Kit contains a non-infectious “Mock Virus Particle” (MVP) that mimics the physicochemical characteristics of live infectious MVM, as well as reagents and components to quantify MVP in solution.
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