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

PROJECT SUMMARY ABSTRACT MockV SolutionsIncMockVis 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 virusesWe 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 virusa contaminant of great concern during the production of biopharmaceuticalsIn factMinute Virus of MiceMVMhas notoriously contaminated several manufacturing facilities over the past couple decades leading to drug shortagestremendous costsand increased regulatory scrutinyBecause of this potentialmammalian derived biopharmaceutics are only approved for clinical or commercial use after their manufacturing processes demonstrate sufficient viral clearanceThis is accomplished through small scalespiking studieswhereby model virusesexMVMare artificially introduced into biopharmaceutical material and removed or inactivated by purification techniquesThese studies require specialized Biological Safety Level laboratoriesBSLand trained personnel resulting in costs that can soar well above $Due to these hurdlesmost companies delay assessmentsthereby increasing the risk of a validation failureValidation 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 therapiesMockV is developing a BSLcompatiblelow cost MVM clearance prediction kit based on the novel use of Virus Like ParticlesVLP sas non infectious surrogates to live infectious MVMUtilized during manufacturing process developmenttheMVM VLP Kitwould provide scientists with a unique tool to generatereal timedata on MVM clearanceWith aQuality by Designapproachthese scientists could confidentially optimize their manufacturing process to clear MVM and determine the efficacy of process steps before investing significant resources in costly validation studiesThe time and resources saved by the MVM VLP Kit would translate into cheaper $ gram manufacturing costs and increase the likelihood of passing regulatory hurdlesViral clearance is an international regulatory requirement for themammalian cell derived BP in worldwide developmentWith the projected cost of a MVM VLP Kit to be $we estimate an annual market value of$M yearTo set us on the path toward commercializationwe 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 noninfectious MVM VLP surrogateAfter successful completion of this Phase I feasibility study we will further optimize and validate the Immuno QPCR assayWe will then conduct extensive beta testing through a series of Design of Experiments studiescomparing MVM VLP clearance to live MVM clearance through variety of purification techniqueschromatographyinactivationfiltrationand representative operating conditions In this Phase I SBIR studyMockV Solutions plans to test the feasibility of accurately predicting Minute Virus of MiceMVMclearance through the use of a non infectious Virus Like Particle KitUsing this kitscientists will be able to develop more efficient biopharmaceutical manufacturing processes and predict viral clearance validation failures prior to expensive regulatory testingThese benefits will reduce the $ gram costs of biopharmaceuticals and ensure the timely regulatory approvals of life altering therapies