SBIR Phase I: Novel pharmaceutical manufacturing technologies to deliver more affordable medications to patients faster and with better quality

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力是，它将使一种突破性的制药制造工艺商业化。该项目包括开发新的工艺技术，以连续(一年365天、每天24小时)制造药物，这与目前在离散时间点生产大量药物的方法不同(例如，每年生产几次大批量药物)。这一过程的工作中试工厂通过上市的药物展示了显著的操作优势？生产时间从200天缩短至2天，工厂占地面积减少90%，成本降低50%，同时提高了产品质量。对社会的影响会很大吗？患者将获得质量更好的药品；药品短缺的风险将大大降低；制药公司将能够以更具成本效益和效率的方式制造和分销药品，使它们能够将更多资金重新分配到研发(可以开发新药)。最后，有可能将制造工厂和工作岗位迁回美国，因为这种制造过程将以非常低的成本生产药物。拟议的项目建立在一家一流的研究机构和一家领先的制药公司之间长达五年的合作基础上，旨在开发一种新的制药制造工艺，以克服当前标准或批量生产工艺的限制。联合努力是成功的；然而，这一新的过程是在大学实验室环境中建立的，还没有准备好进行商业实施。NSF项目的目标是进一步开发这一多步骤制造过程的三个新元素，即单元操作(即膜分离器、旋转过滤器和滚筒干燥器)，使它们坚固耐用，能够在不同的操作条件下运行。这一点很重要，因为商业生产要求它们在连续的基础上始终如一地可靠地运行。因此，这些新颖的单元操作将在不同的操作条件和原料下进行研究，同时对它们的设计和组成进行优化。当单位运营达到：1)最大的运营效率，2)行业标准的制造能力，以及3)在研发和制造领域使用的资格时，成功将被定义为。最终目标是将这三个关键单元操作合并到一个能够连续生产高质量药品的综合制造工艺中。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is that it will enable the commercialization of a groundbreaking manufacturing process for pharmaceuticals. The project consists of the development of novel process technologies to manufacture drugs on a continuous basis (24 hours a day, 365 days a year), which is different from the current methodology that produces large quantities of drugs at discrete time points (e.g. large batch quantities are produced several times a year). A working pilot plant of this process demonstrated significant operational advantages with a marketed drug ? production time was reduced from 200 days to 2 days, plant footprint decreased by 90%, costs reduced by 50%, while improving product quality. The impact on society will be considerable ? patients will receive better quality drugs; the risk of drug shortages will be greatly reduced; and pharmaceutical companies will be able to manufacture and distribute their drugs in a much more cost-effective and efficient manner, allowing them to reallocate more capital to Research and Development (new drugs can be developed). Finally, it will be possible to relocate manufacturing plants and jobs back in the U.S., as this manufacturing process will produce drugs very cheaply.The proposed project builds upon five years of collaboration between a premier research institution and a leading pharmaceutical company aimed at developing a novel manufacturing process for pharmaceuticals that will overcome the limitations of the current standard, or batch manufacturing process. The joint endeavor was successful; however, the novel process was built in a university laboratory setting, and is not ready for commercial implementation. The objective of this NSF project is to further develop three novel elements, or unit operations of this multistep manufacturing process (i.e. a membrane separator, a rotary filter and a drum dryer), so they are robust and able to run under different operating conditions. This is important because commercial production requires that they perform consistently and reliably on a continuous basis. Thus, these novel unit operations will be studied under different operating conditions and starting materials, while their design and compositions are optimized. Success will be defined when the unit operations achieve: 1) maximal operational efficiency, 2) industry standard manufacturing capabilities, and 3) qualification to be used across the Research and Development manufacturing spectrum. The end goal is to incorporate these three critical unit operations into an integrated manufacturing process capable of producing high-quality pharmaceuticals on a continuous basis.