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

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力是，它将使突破性的药品制造工艺商业化。该项目包括开发新的工艺技术，以连续生产药物（每天24小时，一年365天），这与目前在离散时间点生产大量药物的方法不同（例如，大批量生产一年几次）。该工艺的中试工厂对已上市的药物具有显著的操作优势？生产时间从200天减少到2天，厂房占地面积减少90%，成本降低50%，同时提高了产品质量。对社会的影响将是相当大的？患者将获得更优质的药物；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生产和分销药品，使它们能够将更多资金重新分配给研发（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个主要研究机构和一个领先的制药公司之间的五年合作基础上，旨在开发一种新的药品制造工艺，该工艺将克服当前标准或批量生产工艺的限制。共同努力取得了成功；然而，这种新工艺是在大学实验室环境中建立的，还没有为商业实施做好准备。这个NSF项目的目标是进一步开发这个多步骤制造过程的三个新元素或单元操作（即膜分离器，旋转过滤器和滚筒干燥器），因此它们是坚固的，能够在不同的操作条件下运行。这一点很重要，因为商业生产需要它们在连续的基础上稳定可靠地运行。因此，这些新颖的单元操作将在不同的操作条件和起始材料下进行研究，同时对其设计和组成进行优化。当单元操作达到以下目标时，将定义成功：1)最大的操作效率，2)行业标准制造能力，以及3)在研发制造范围内使用的资格。最终目标是将这三个关键单元操作合并到能够连续生产高质量药品的集成制造过程中。

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.