GENNEXT TECHNOLOGIES, INC. SBIR Phase I Award, January 2018

The GenNext submssion entitledFoxWarean Advanced Data Analysis Package for Hydroxyl Radical Foot printing Higher Order Structural Analysisis responsive to the ackowledged need for new and improved tools for higher order structural analysisHOSof biopharmaceuticalsBiopharmaceuticals are complexheterogeneous mixtures ofdimensional biomoleculeswhose safety and efficacy is reliant upon proper HOSThe presence of proteins with improper HOS has been linked to severe adverse drug reactionsADRestablishing the need for new and improved HOS analyticsAn emerging HOS analysis technique is hydroxyl radical foot printingHRPFHRPF involves the irreversible labeling of a protein s exterior by reaction with hydroxyl radicals with subsequent MS analysis to identify the outer portions of the proteinThe most widely used method for generating OH radicals employs a quick burst of UV lightand is appropriately called fast photochemical oxidation of proteinsFPOPAcademic laboratories have demonstrated the utility of FPOP for HOS analysishowever adoption in pharma has been minuscule at bestGuided by the critiques of scientists at leading biopharmaceutical companieswe have identified barriers that have limited pharma s adoption of FPOP HRPFA substantial barrier is the absence of data processing tools to facilitate HRPF analysisToday there are no commercial solutions for FPOP analysisdespite the demonstrated market need for its HOS analytical powerToday s proteomics data analysis products fail to adequately address specific work flowchemical labelingartifactsand comparative study requirements of HRPF HOS analysisResearchers are compelled to use a piece meal approacharduously stitching together results from multiple packages and manually manipulating data in home brew spreadsheetsAs suchdata processing represents a significant bottleneck that greatly complicates and delays progress in HRPF HOS studiesOur FoxWaresoftware addresses data processing demands of HRPF HOS analysisOur proposal vastly improves HRPF data analysis by replacing laborious and agonizing present day practices with an integratedseamless solution to interpret and amplify the value of HRPF HOS studiesUpon completion of our envisioned programFoxWare will make an indelible mark upon HOS analysis and impart a transformative shift in analytics and HRPF throughputaddressing the market demands of the biopharmaceutical industry The importance of large protein drugsbiopharmaceuticalsand their generic counterpartsknow as biosimilarshas created a need for improved analytics to facilitate biopharmaceutical research and to combat adverse drug reactionsThe biopharmaceutical industry acknowledges the critical role that protein structure plays in the safety and function of biotherapeuticsConsequentlythe U Sgovernment has issued guidelines that call for the use and development of state of the art technology for evaluating bipharmaceutical protein structureThe GenNext Phase I SBIR will demonstrate feasibility of an improved data processing software program to analyze protein higher order structureUpon successful completion of our programwe will demonstrate the transformative nature of our new technology to positively impact biopharmaceutical research