PROJECT SUMMARY/ABSTRACT
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).
