NovaAPI: Terminal Sterilization of Drug Substances and Products

项目摘要/摘要 NovaSterilis，Inc.打算开发其基于超临界碳的新型灭菌平台并将其商业化 二氧化碳(SCCO2)和强大的灭菌剂，制药市场的NovaKill™-NovaAPI™。药品的灭菌 物质(或活性药物成分；原料药)和药品是一个具有挑战性的应用，因为 许多药物和生物制品的复杂性以及当前灭菌方式(例如，蒸汽， 辐射、环氧乙烷)。制药业的灭菌通常只针对符合以下条件的药物 转向最终组装(即无菌加工和包装)，这不能提供 绝育手术。打算灭菌的产品应尽可能在其最终容器中进行终端灭菌 根据FDA的说法(称为终端灭菌)。然而，利用终端的药品很少 灭菌，以及密封容器中的药品(例如，冻干药品或配方药品)或 预装注射器，制药公司唯一的选择是使用无菌工艺对这些产品进行最终组装， 这是一个耗时和耗费资源的过程。虽然全球药品绝育服务市场规模很大 大约60亿美元，为药品制造商提供最终消毒含药最终产品的解决方案 将会改变游戏规则。到2021年底，仅全球预充式注射器市场估计就将达到54亿美元， 而目前，这些产品最终组装的唯一解决方案是通过无菌加工。这表示一个 NovaSterilis NovaAPI™解决方案的重大机遇，在提供更安全的 产品，消除了对工艺兼容产品的无菌加工的需要，并扩大了数量和 可进行终端灭菌的药物物质/产品的类型。 先前的研究结果支持继续开发NovaSterilis药物灭菌平台 和有潜力为瓶装/注射器中的最终药物产品开发终端灭菌工艺的产品 格式化。我们已经与一家全球领先的消毒服务公司合作，为更广泛的计划提供 对项目具有重要的应用、客户和市场洞察力。IFyber在这方面提出了以下具体目标 使NovaAPI™商业化的快速通道提案： 第一阶段的具体目标： ·目标1：使用NovaAPI™为选定数量的药物建立药物物质配伍矩阵 ·目标2：为最终产品的最终灭菌建立基线条件 第二阶段的具体目标： ·目标3：完成对SAL 10-6药物物质/产品灭菌验证过程的评估。 ·目标4：按照监管准则完成灭菌残留物测试。 ·目标5：在100L船舶上建立放大工艺参数和装载配置。

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.