NovaAPI: Terminal Sterilization of Drug Substances and Products

NovaAPI：原料药和产品的最终灭菌

• 批准号: 10547237
• 负责人: Aaron D Strickland
• 金额: $ 24.23万
• 依托单位: NOVASTERILIS, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-11 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10547237
• 关键词: Address; Biological Products; Carbon Dioxide; Computer software; Consumption; Development; Drug Industry; Drug usage; Equipment; Ethylene Oxide; Freeze Drying; Guidelines; Human Resources; Industry; Manufacturer Name; Medical Device; Methods; Modality; Pharmaceutical Preparations; Pharmaceutical Technology; Pharmacologic Substance; Phase; Process; Radiation; Research; Residual state; Resources; Risk; Sales; Services; Steam; Sterility; Sterilization; Syringes; Techniques; Technology; Testing; Therapeutic; Time; Training and Education; United States National Institutes of Health; Validation; Vial device; Work; base; cold temperature; commercialization; cost; drug market; innovation; insight; novel; programs; scale up; seal

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.

项目总结/摘要 NovaSterilis，Inc.打算开发并商业化其基于超临界碳的新型灭菌平台 二氧化物（scCO 2）和强大的杀菌剂，NovaKill™用于制药市场- NovaAPI™。药物灭菌 物质（或活性药物成分; API）和药物产品是一个具有挑战性的应用， 许多药物和生物制剂的复杂性以及当前灭菌方式的最小兼容性（例如，蒸汽， 辐射、环氧乙烷）。制药工业中的灭菌通常仅保留给 移动到最终组装（即，无菌处理和包装），其不提供 灭菌预期无菌的产品应尽可能在其最终容器中进行最终灭菌 （称为最终灭菌）。然而，很少有药物产品利用终端 灭菌，以及对于密封容器中的药物产品（例如，冻干药物或配制药物）或 对于预充式注射器，制药公司的唯一选择是使用无菌工艺来最终组装这些产品， 这是一个耗时且资源繁重的过程。虽然全球药物消毒服务市场规模巨大， 约60亿美元，为药品制造商提供最终灭菌含药终端产品的解决方案 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， 目前，这些产品的最终组装的唯一解决方案是通过无菌处理。这表示 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处理的需要， 可进行最终灭菌的原料药/产品类型。 先前的研究结果支持继续开发用于原料药灭菌的NovaSterilis平台 以及有可能为小瓶/注射器中的最终制剂开发最终灭菌工艺的产品 格式.我们与灭菌服务领域的全球领导者合作，开展更广泛的计划， 对项目的重要应用、客户和市场洞察力。iFyber提出了以下具体目标， 为NovaAPI™商业化做准备的快速通道提案： 第一阶段具体目标： ·目标1：使用NovaAPI™为选定数量的药物建立原料药相容性矩阵 ·目标2：建立最终产品最终灭菌的基线条件 第二阶段具体目标： ·目标3：完成原料药/产品SAL 10-6的灭菌验证过程评估。 ·目标4：按照监管指南完成灭菌残留物测试。 ·目标5：在100 L容器中建立放大工艺参数和负载配置。