MockV Solutions, Inc. (MockV) is an early stage company creating viral-surrogate tools that solve the unmet needs of scientists as they develop and optimize products and techniques in a variety of industries that currently rely on expensive and logistically challenging live virus analysis. Virus is a contaminant of great concern during biopharmaceutical production. Because of this concern, international regulatory agencies require proof that manufacturing steps such as chromatography or nanofiltration can effectively remove virus. This is accomplished through small scale ?spiking studies? whereby model viruses (ex. Minute Virus of Mice) are artificially introduced into biopharmaceutical material and removed or inactivated by purification techniques. These studies require specialized Biological Safety Level laboratories (BSL) and trained personnel resulting in costs that can soar well above $100,000. Due to these hurdles, most companies delay assessments, thereby increasing the risk of failure leading to cost over-runs and delayed regulatory approval which can cost a company valuable revenue/patent life and cost patients timely access to therapies. MockV is developing a BSL-1 compatible, low cost MVM clearance prediction kit based on the novel use of Virus Like Particles (VLP?s) as non-infectious surrogates to live infectious MVM. Utilized during manufacturing process development, the ?MVP Kit? would provide scientists with a unique tool to generate ?real time? data on MVM clearance. With a ?Quality by Design? approach, these scientists could more efficiently engineer their manufacturing process to clear MVM and determine the efficacy of process steps before investing significant resources in costly validation studies. The time and resources saved by the MVP Kit would translate into manufacturing cost of goods and increase the likelihood of passing regulatory hurdles. This project will fund efforts to advance the MVP Kit toward commercialization through product development and applications testing efforts. First, we will optimize MVP production through small scale cell expression screening experiments and downstream chromatography process development efforts. We will also establish analytical MVP Quality Control metrics. After scale-up, we will produce MVP to support applications testing. In this phase of the project, we will be collaborating with REGENX BIO and Chromatan, to assess the utility of MVP for gene therapy and continuous processing applications. During this phase, spiking studies will be conducted to compare the removal of MVP vs live MVM. The data generated could support the use of the MVP Kit in these two emerging and important markets. Finally, we will develop a second-generation proximity ligation assay for quantifying MVP in high throughput screening applications. After successful completion of this Phase II study we will conduct extensive beta testing prior to commercialization.
In this Phase 2 SBIR study, MockV Solutions plans to demonstrate the ability of its MVP Kit to predict viral clearance during gene therapy and continuous processing applications. Using this kit, scientists will be able to engineer more efficient biopharmaceutical manufacturing processes and predict viral clearance validation failures prior to expensive regulatory testing. These benefits will reduce biopharmaceutical manufacturing costs of goods and help ensure the timely regulatory approvals for life-altering therapies.