Demonstrating Utility of a Non-Infectious Minute Virus of Mice-Virus Like Particle for Predicting Viral Clearance during Biopharmaceutical Process Development

Period of Performance: 12/01/2017 - 11/30/2018

$250K

Phase 1 SBIR

Recipient Firm

Mockv Solutions, Inc.
ROCKVILLE, MD 20850
Principal Investigator

Abstract

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.