MockV Solutions, Inc. (MockV) is an early stage company creating viral-surrogate tools that solve the unmet needs of biopharmaceutical process development scientists as they develop manufacturing techniques to purify their therapeutics while removing or inactivating virus; a contaminant of great concern during the production of biopharmaceuticals. In fact, mammalian cell lines typically used for biopharmaceutical production endogenously produce retrovirus like particles (RVLP?s). Although non-infectious, the potential for reversion has caused global regulators to approve mammalian derived biopharmaceutics for clinical or commercial use only after their manufacturing processes demonstrates sufficient retroviral clearance capabilities. This is accomplished through small scale ?spiking studies? whereby model viruses (ex. Xenotropic Murine Leukemia Virus, XMuLV) 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 a validation failure. Validation failures lead 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 retrovirus clearance prediction kit based on a purified and concentrated stock solution of non- infectious RVLP?s Utilized during manufacturing process development, the ?RVLP Kit? would provide scientists with a unique tool to generate ?real time? data on retroviral clearance. With a ?Quality by Design? approach, these scientists could confidentially optimize their manufacturing process to clear retrovirus and determine the efficacy of process steps before investing significant resources in costly validation studies. The time and resources saved by the RVLP Kit would translate into cheaper $/gram manufacturing costs and increase the likelihood of passing regulatory hurdles. Viral clearance is an international regulatory requirement for the ~6,000 mammalian cell derived BP in worldwide development. With the projected cost of a RVLP Kit to be $2,500, we estimate an annual market value of ~$95M/year. To set us on the path toward commercialization, we propose to first test the feasibility of economically producing a highly purified and concentrated stock solution of RVLP. After successful completion of this Phase I feasibility study we will conduct extensive clearance testing, comparing RVLP clearance to live XMuLV clearance through variety of purification techniques (chromatography and nanofiltration).
In this Phase I SBIR study, MockV Solutions plans to test the feasibility of producing a highly purified and concentrated stock solution of non-infectious Retrovirus Like Particles (RVLP). This stock solution would serve as the centerpiece of a commercial Kit, enabling scientists to develop more efficient biopharmaceutical manufacturing processes and predict viral clearance validation failures prior to expensive regulatory testing. These benefits will reduce the $/gram costs of biopharmaceuticals and ensure the timely regulatory approvals of life-altering therapies.