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MockV Solutions Announces Phase 1 SBIR Grant Award from the Center for Drug Evaluation and Research (CDER), FDA – MockV Solutions

MockV Solutions Announces Phase 1 SBIR Grant Award from the Center for Drug Evaluation and Research (CDER), FDA

Rockville, MD – December 5th, 2018 – MockV Solutions, Inc. (MockV or the Company), a biotechnology company developing non-infectious viral clearance prediction products that address the unmet needs of process development scientists as they establish biopharmaceutical manufacturing platforms, announced today the receipt of a Phase I grant from the Center for Drug Evaluation and Research under auspices of the Small Business Innovation Research (SBIR) program of the FDA. The $150,000 grant under the Grant Number 1R43FD006472-01 is focused on generating a highly purified and concentrated stock solution of non-infectious Retrovirus Like Particles (RVLP’s) and demonstrating their utility for screening viral clearance during biopharmaceutical process development.

Mr. David Cetlin, MS, CEO of MockV said, “We are very pleased to receive this SBIR grant from CDER which supports the development and commercialization of our second MVP Kit. This Kit which enable scientists to track retroviral clearance on their own bench tops and will thus allow for viral clearance screening to take place during process development and optimization, building quality into their processes ahead of validation and regulatory filings.”


About MockV Solutions 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 Virus like Particle (VLP) or “Mock Virus Particle” (MVP) that
mimics the physicochemical characteristics of live infectious MVM, as well as reagents and components to quantify MVP in solution. Prototypes are available for sale.

For further information regarding MockV Solutions, Inc., please visit the Company’s website at www.mockvsolutions.com.