NOVASTERILIS, INC. — Department of Health and Human Services SBIR Phase II: R

Description

Project Summary The process combining supercritical COand co sterilants produces strong synergistic microbicidal effects in relatively mild conditionsThe mechanism of microbe inactivation is not well characterizedbut the disruption of lipid membranes and mild oxidative damage appear to be involvedThe processwhich is also highly efficient against virusesis considered to be very mild compared to other sterilization methodsExperimental evidence shows that damage to protein is limitedand that immunogenic epitopes can survive the processIn this project NovaSterilis will seek to optimize the supercritical COsterilization process for broad and effective virucidal treatments while attempting to maintain the integrity of model proteinsThe first goal is to fully validate the supercritical process against viruses as a method that could replaceradiations which fail at effective virus inactivation and damage sensitive productsThe second goal will be to characterize and optimize the supercritical sterilization process for the sterilization of proteinsProteins have become increasingly popular as vaccinestherapeuticsand in combination devicesYettheir sterilization remains extremely challengingIn collaboration with the group of Bryce Chackerian at the University of New Mexicoand DrStephen Eyles and Professor Igor Kaltashov at UMass Amherstthe effect of supercritical sterilization on growth factors and recombinant vaccines will be studied with in vitro and in vivo functional assayand will for the first time use state of the art mass spectrometry to determine with great precision the effect of scCOitself or combined with a sterilant on the conformation and oxidation status of model proteins