Rockville, MD – October 21, 2019 – 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 that a scientific manuscript detailing a comparative proof of concept study between Minute Virus of Mice (MVM) and its non-infectious MVM-Mock Virus Particles (MVM-MVP) and has been accepted for publication in the scientific journal Biotechnology Progress (https://doi.org/10.1002/btpr.2921).
The study was conducted in collaboration with AstraZeneca (MedImmune) and Texcell – North America, Inc. Anion Exchange Chromatography (AEX) and Virus Filtration (VF) experiments were conducted with IgG loads spiked with either MVM or MVM-MVP. Results demonstrated the ability to predict MVM removal with the non-infectious MVM-MVP, measured via an Immuno-qPCR assay. “This data implies that MVM-MVP’s may be useful as an accurate MVM surrogate during typical downstream process operations such as anion exchange chromatography and nanofiltration”, said MockV Founder and CEO David Cetlin. “MockV is currently providing this BSL-1 compatible particle as part of the MVM-MVP Kit – the first commercial kit of its kind which is helping scientists incorporate robust viral clearance into their biopharmaceutical processes. This vision dovetails with ‘Quality by Design’ principles and aligns nicely with similar products on the market such as Host Cell Protein and residual Protein A Kits.”
A link to the article is provided here:
Full text of the article will be available in an upcoming print version of the journal or through contacting MockV Solutions at: firstname.lastname@example.org
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 first commercial product, 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.
For further information regarding MockV Solutions, Inc., please visit the Company’s website at www.mockvsolutions.com.
About Texcell North America, Inc.
Texcell-North America, Inc. is a global contract research organization based in the Maryland/Virginia biotech corridor specializing in custom cell culture, virus propagation, virus concentration, viral clearance services, and viral safety testing in support of biopharmaceutical applications submitted to the FDA and other regulatory authorities. Since 2002, our team has cultivated an ever-increasing range of experience performing viral clearance studies for a wide variety of purification steps including chromatography, filtration, and inactivation methods, as well as evaluations of column age and sanitization, or cleaning efficacy. We offer our clients a personalized and tailored approach to study design with the advantage of an extensive historical viral clearance database of over 10,000 studies performed by our global organization. Through partnerships with other Texcell facilities around the world, we have expanded our services portfolio to include cGMP cell bank production, cell bank characterization and GMP compliant animal studies. We are proud to support research that continues to improve global quality of life.
For further information regarding Texcell, please visit: http://www.texcell.com/