SBIR-STTR Award

NovaSterilis, Inc. intends to develop and commercialize its novel sterilization platform based on supercritical carbondioxide (scCO2) and powerful sterilant, NNovaKill™ for the pharmaceutical market - NNovaKill™. Sterilization of drugsubstances (or active pharmaceutical ingredients; APIs) and drug products is a challenging application due to thecomplexities 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 thatmove onto final assembly (i.e., aseptic processing and packaging), which does not provide the level of protection ofsterilization. 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 terminalsterilization, and with respect to drug products in sealed containers (e.g., lyophilized drugs or formulated drugs) orprefilled 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 significantat roughly $6 billion USD, offering solutions to drug manufacturers for terminally sterilizing drug containing end productswould 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 asignificant opportunity for the NovaSterilis NovaAPI™ solution, with the potential for enormous upside in providing saferproducts, eliminating the need for aseptic processing for process-compatible products and expanding on the number andtype of drug substances/products that can be terminally sterilized.Previous research results support continued development of the NovaSterilis platform for sterilization of drug substancesand products with the potential for developing a terminal sterilization process for final drug products in vial/syringeformat. We have partnered with a global leader in sterilization services for the broader program, which should providesignificant application, customer, and market insight to the project. iFyber has proposed the following Specific Aims in thisFast 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 productsPhase 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.

Public Health Relevance Statement:
NARRATIVE 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). This effort will draw form previous research results that support the 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.

Project Terms:

NovaSterilis, Inc. intends to develop and commercialize its novel sterilization platform based on supercritical carbondioxide (scCO2) and powerful sterilant, NovaKill™ for the pharmaceutical market - NovaAPI™. Sterilization of drugsubstances (or active pharmaceutical ingredients; APIs) and drug products is a challenging application due to thecomplexities 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 thatmove onto final assembly (i.e., aseptic processing and packaging), which does not provide the level of protection ofsterilization. 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 terminalsterilization, and with respect to drug products in sealed containers (e.g., lyophilized drugs or formulated drugs) orprefilled 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 significantat roughly $6 billion USD, offering solutions to drug manufacturers for terminally sterilizing drug containing end productswould 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 asignificant opportunity for the NovaSterilis NovaAPI™ solution, with the potential for enormous upside in providing saferproducts, eliminating the need for aseptic processing for process-compatible products and expanding on the number andtype of drug substances/products that can be terminally sterilized.Previous research results support continued development of the NovaSterilis platform for sterilization of drug substancesand products with the potential for developing a terminal sterilization process for final drug products in vial/syringeformat. We have partnered with a global leader in sterilization services for the broader program, which should providesignificant application, customer, and market insight to the project. iFyber has proposed the following Specific Aims in thisFast 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 productsPhase 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.

Public Health Relevance Statement:
NARRATIVE 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). This effort will draw form previous research results that support the 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.

Project Terms: