Project Grant R44AI170431

NOVAAPI: TERMINAL STERILIZATION OF DRUG SUBSTANCES AND PRODUCTS - PROJECT SUMMARY / ABSTRACT NOVASTERILIS, INC. INTENDS TO DEVELOP AND COMMERCIALIZE ITS NOVEL STERILIZATION PLATFORM BASED ON SUPERCRITICAL CARBON DIOXIDE (SCCO2) AND POWERFUL STERILANT, NOVAKILL FOR THE PHARMACEUTICAL MARKET - NOVAAPI. STERILIZATION OF DRUG SUBSTANCES (OR ACTIVE PHARMACEUTICAL INGREDIENTS; APIS) AND DRUG PRODUCTS IS A CHALLENGING APPLICATION DUE TO THE COMPLEXITIES OF MANY DRUGS AND BIOLOGICS AND THE MINIMAL COMPATIBILITY OF CURRENT STERILIZATION MODALITIES (E.G., STEAM, RADIATION, ETHYLENE OXIDE). STERILIZATION IN THE PHARMACEUTICAL INDUSTRY IS TYPICALLY RESERVED ONLY FOR DRUG SUBSTANCES THAT MOVE ONTO FINAL ASSEMBLY (I.E., ASEPTIC PROCESSING AND PACKAGING), WHICH DOES NOT PROVIDE THE LEVEL OF PROTECTION OF STERILIZATION. PRODUCTS INTENDED TO BE STERILE SHOULD BE TERMINALLY STERILIZED IN THEIR FINAL CONTAINER WHENEVER POSSIBLE (REFERRED TO AS TERMINAL STERILIZATION) ACCORDING TO THE FDA. HOWEVER, THERE ARE VERY FEW DRUG PRODUCTS THAT UTILIZE TERMINAL STERILIZATION, AND WITH RESPECT TO DRUG PRODUCTS IN SEALED CONTAINERS (E.G., LYOPHILIZED DRUGS OR FORMULATED DRUGS) OR PREFILLED SYRINGES, THE ONLY OPTION FOR DRUG COMPANIES IS TO USE ASEPTIC PROCESSING FOR FINAL ASSEMBLY OF THESE PRODUCTS, WHICH IS A TIME CONSUMING AND RESOURCE HEAVY PROCESS. WHILE THE GLOBAL STERILIZATION SERVICES MARKET FOR DRUGS IS SIGNIFICANT AT ROUGHLY $6 BILLION USD, OFFERING SOLUTIONS TO DRUG MANUFACTURERS FOR TERMINALLY STERILIZING DRUG CONTAINING END PRODUCTS WOULD BE A GAME CHANGER. THE GLOBAL PREFILLED SYRINGE MARKET ALONE IS ESTIMATED TO BE $5.4 BILLION USD BY THE END OF 2021, AND CURRENTLY, THE ONLY SOLUTION FOR FINAL ASSEMBLY OF THESE PRODUCTS IS THROUGH ASEPTIC PROCESSING. THIS REPRESENTS A SIGNIFICANT OPPORTUNITY FOR THE NOVASTERILIS NOVAAPI SOLUTION, WITH THE POTENTIAL FOR ENORMOUS UPSIDE IN PROVIDING SAFER PRODUCTS, ELIMINATING THE NEED FOR ASEPTIC PROCESSING FOR PROCESS-COMPATIBLE PRODUCTS AND EXPANDING ON THE NUMBER AND TYPE OF DRUG SUBSTANCES/PRODUCTS THAT CAN BE TERMINALLY STERILIZED. PREVIOUS RESEARCH RESULTS SUPPORT CONTINUED DEVELOPMENT OF THE NOVASTERILIS PLATFORM FOR STERILIZATION OF DRUG SUBSTANCES AND PRODUCTS WITH THE POTENTIAL FOR DEVELOPING A TERMINAL STERILIZATION PROCESS FOR FINAL DRUG PRODUCTS IN VIAL/SYRINGE FORMAT. WE HAVE PARTNERED WITH A GLOBAL LEADER IN STERILIZATION SERVICES FOR THE BROADER PROGRAM, WHICH SHOULD PROVIDE SIGNIFICANT APPLICATION, CUSTOMER, AND MARKET INSIGHT TO THE PROJECT. IFYBER HAS PROPOSED THE FOLLOWING SPECIFIC AIMS IN THIS FAST TRACK PROPOSAL TO PREPARE NOVAAPI FOR COMMERCIALIZATION: PHASE I SPECIFIC AIMS: AIM 1: ESTABLISH A DRUG SUBSTANCE COMPATIBILITY MATRIX FOR A SELECT NUMBER OF DRUGS USING NOVAAPI AIM 2: ESTABLISH BASELINE CONDITIONS FOR TERMINAL STERILIZATION OF END PRODUCTS PHASE II SPECIFIC AIMS: AIM 3: COMPLETE ASSESSMENT OF STERILIZATION VALIDATION PROCESS FOR SAL 10-6 FOR DRUG SUBSTANCES/PRODUCTS. AIM 4: COMPLETE STERILIZATION RESIDUALS TESTING FOLLOWING REGULATORY GUIDELINES. AIM 5: ESTABLISH SCALE UP PROCESS PARAMETERS AND LOAD CONFIGURATION IN A 100L VESSEL.