Rockville, MD – Nov 27, 2017 – 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 it will be collaborating with MedImmune LLC to evaluate its MVM-MVP Kit. The MVM-MVP Kit contains a non-infectious “Mock Virus Particle” (MVP) that mimics the physicochemical characteristics of Minute Virus of Mice (MVM) and quantification reagents for clearance analysis. 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.
MVM, a small and physiochemically resistant parvovirus, is an international standard for assessing viral clearance during regulatory required validation studies. Currently, assessments are made by propagated and spiking infectious MVM into biopharmaceutical material, processing the material through a scale down version of a manufacturing process step and determining the removal efficiency of the challenged process step. 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 that meet viral clearance regulatory requirements.
“We enthusiastically support MockV in its efforts to establish a series of tools that will enable us to economically and easily analyze viral clearance during process development and characterization,” stated Dr. Matthew Dickson (PhD), Associate Director of R&D at MedImmune. “We are working with MockV to progress this technology and share their vision of incorporating viral clearance as a measurable output during typical process development and optimization activities.”
“We look forward to working with MedImmune as we advance our lead product toward commercialization,” stated David Cetlin M.S. Chief Executive Officer of MockV. “Both MockV and MedImmune believe 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 and advance the capabilities of our industry.”