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 techniques in a variety of fields that currently rely on expensive and
logistically challenging live viruses. We are currently focused on developing a novel series of assay kits which
will enable biopharmaceutical scientists to study the efficacy of manufacturing techniques intended to remove
or inactive virus; a contaminant of great concern during the production of biopharmaceuticals. In fact, Minute
Virus of Mice (MVM) has notoriously contaminated several manufacturing facilities over the past couple
decades leading to drug shortages, tremendous costs, and increased regulatory scrutiny. Because of this
potential, mammalian derived biopharmaceutics are only approved for clinical or commercial use after their
manufacturing processes demonstrate sufficient viral clearance. This is accomplished through small scale
“spiking studies” whereby model viruses (ex. MVM) 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 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 “MVM-VLP 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 confidentially optimize 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 MVM-VLP 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 MVM-VLP
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 develop an Immuno-QPCR assay capable of quantifying MVM-VLP and
then utilizing this assay to test the feasibility of accurately predicting live MVM clearance with our non-
infectious MVM-VLP surrogate. After successful completion of this Phase I feasibility study we will further
optimize and validate the Immuno-QPCR assay. We will then conduct extensive beta testing through a series
of Design of Experiments studies, comparing MVM-VLP clearance to live MVM clearance through variety of
purification techniques (chromatography, inactivation, filtration) and representative operating conditions.