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.

该小型企业创新研究 (SBIR) 第一阶段项目的更广泛影响/商业潜力是改进价值 5000 亿美元的药品制造市场中使用的关键步骤：活性药物成分的纯化。百分之九十的活性药物成分都是通过结晶纯化的，但是，从商业和科学的角度来看，目前的结晶方法都存在缺陷。这些技术难以扩大规模，维护和制造成本昂贵，并且受到条件和结果不一致和缺乏统一性的困扰。随着此处提出的技术的开发和商业化，该团队将解决可扩展性、成本和不一致问题，以便：1）加快向先进制造方法（连续制造）的过渡，2）促进生产的重新外包药品制造，有助于解决美国对外国药品制造商的依赖所带来的国家安全挑战；3）降低药品生产成本，这最终将导致更便宜的药品造福于全体人民。该SBIR第一期项目提议开发一种创新的连续结晶装置，该装置可扩展，提供充分且有效的固体运动，并提供高质量的结晶产品，从而满足制药市场和技术界未满足的需求。这种新颖的设计旨在有效解决移动固体（晶体）的问题，同时通过可从实验室扩展到生产的方法提供良好控制的流动特性。该技术结合了多种原始功能，提供了一种解决这些运输挑战的新技术方法。该团队将首先演示具有活塞流特性的浆料输送能力。然后，该团队将演示药物的结晶，并将其与标准批量结晶方法进行比较。一旦该技术被证明在这些条件下运行良好，该设备将被扩大规模，以便在生产规模上进行测试和使用。一旦完成，该商业化设备预计将能够克服其他技术的问题，包括运输、均匀性、一致性、再现性和成本问题，使这种新颖的设备成为未来药品制造的关键参与者。该奖项反映了 NSF 的法定使命，并通过使用基金会的智力优点和更广泛的影响审查标准进行评估，被认为值得支持。