SBIR Phase I: Continuous, Scalable Crystallizer for Pharmaceutical Manufacturing

SBIR 第一阶段：用于药品制造的连续、可扩展结晶器

• 批准号: 2233759
• 负责人: Andrea Adamo
• 金额: $ 27.5万
• 依托单位: Zaiput Flow Technologies LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-15 至 2024-04-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2233759&HistoricalAwards=false
• 关键词: SBIR; Phase; Continuous; Scalable; Crystallizer

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to improve a key step used in the $500-billion market of pharmaceutical manufacturing: purification of active pharmaceutical ingredients. Ninety percent of all active pharmaceutical ingredients are purified using crystallization, however, current approaches to crystallization have drawbacks from both the commercial and scientific points of view. These techniques are difficult to scale up, are expensive to maintain and manufacture, and are plagued by inconsistency and lack of uniformity in conditions and results. With the development and commercialization of the technology proposed here, this team will address the scalability, cost, and inconsistency issues in order to: 1) speed up the transition to advanced manufacturing approaches (continuous manufacturing), 2) facilitate the re-shoring of drug manufacturing, contributing to addressing the national security challenge of American dependence on foreign drug manufacturers, and 3) reduce drug production costs, which will eventually lead to cheaper drugs for the benefit of the entire population. This SBIR Phase I project proposes to develop an innovative, continuous crystallization device that is scalable, provides adequate and effective movement of solids, and provides high-quality crystalline products, thus fulfilling an unmet need in the pharmaceutical market and in the technical community. The novel design aims to solve the problem of moving solids (crystals) effectively while providing well-controlled flow characteristics with an approach that is scalable from lab to production. This technology uses a combination of several original features to provide a new technological approach to address these transport challenges. This team will first provide a demonstration of the ability to transport slurries with plug flow characteristics. Then, the team will demonstrate the crystallization of a pharmaceutical, benchmarking it against standard batch crystallization methods. Once the technology has been shown to function well in these conditions, the device will be scaled up, in order to be tested and used at production scale. Once complete, the commercialized device is expected to be able to overcome problems with other technologies, including issues of transport, uniformity, consistency, reproducibility, and cost, making this novel device a key player in the future of pharmaceutical manufacturing.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

这项小型企业创新研究（SBIR）I阶段项目的更广泛的影响/商业潜力是改善500亿美元的药品制造市场中使用的关键步骤：活跃药品成分的纯化。在所有活性药物成分中，有90％使用结晶纯化，但是，当前的结晶方法从商业和科学的观点都具有缺点。这些技术难以扩大，维护和制造很昂贵，并且由于条件和结果的统一性不一致而困扰。随着此处提出的技术的开发和商业化，该团队将解决以下方面的可伸缩性，成本和不一致问题，以加快对高级制造方法的过渡（连续制造），2）促进对药物制造的重新构造，促进对美国对外国药物生产的国家安全挑战的挑战，并降低造成药物的兴趣，这将降低CHEA，以降低CHEA的责任，从而减少对国家的依赖的挑战。 SBIR I期项目提议开发一种可扩展的创新，连续的结晶装置，提供固体的足够有效运动，并提供高质量的结晶产品，从而满足制药市场和技术群落中未满足的需求。新颖的设计旨在解决有效地移动固体（晶体）的问题，同时通过可扩展的从实验室到生产的方法提供良好控制的流动特性。该技术结合了几种原始功能，提供了一种新的技术方法来应对这些运输挑战。该团队将首先提供以插头流特性运输浆液的能力。然后，团队将展示药物的结晶，并根据标准批次结晶方法进行基准测试。一旦该技术在这些条件下表现出良好的功能，将对设备进行扩展，以便在生产规模上进行测试和使用。 Once complete, the commercialized device is expected to be able to overcome problems with other technologies, including issues of transport, uniformity, consistency, reproducibility, and cost, making this novel device a key player in the future of pharmaceutical manufacturing.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.