PROJECT SUMMARY/ABSTRACT
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.
