I-Corps: Transforming Personalized Medicine With Printed Medicine

这个I-Corps项目更广泛的影响/商业潜力是彻底改变个性化医疗。在复合药房或医院临床药房中使用该技术，可以为患者开出有限数量的一次性药物组合，针对其个体生理学进行定制，并且药房可以在几分钟内为该患者生产这种定制产品以达到高质量规格。患者可以是人类或动物，因为这些挑战存在于人类和动物健康中。拟议工作的长期有益结果将包括：（1）患者将在数小时而不是数月内获得稳定的剂量;（2）具有挑战性的患者亚群将拥有为其代谢量身定制的产品;（3）迄今为止由于严重的保质期限制而无法商业化的已知救生药物可以变得可行;（4）改变个体化医疗和医药产品供应链。I-Corps项目使个体化医疗成为可能。该技术类似于喷墨打印机，在片剂和胶囊等基质上打印精确数量的药物。我们过去的研究已经证明，精密打印非常适合制药生产应用。高精度微流体和过程分析技术已被用于验证通过印刷制造的药品的数量和质量，并且概念验证已经得到了充分的证实。在严格的个体剂量水平下，常规实现优于1%相对标准偏差的精密度。该项目将导致更广泛地采用精密生产，增材制造，即时生产，应用微流体和先进的工艺管理。

The broader impact / commercial potential of this I-Corps project is to completely transform personalized medicine. With this technology in a compounding pharmacy or hospital clinical pharmacy, a patient can be prescribed a one-off combination of drug substances in limited quantities, customized for their individual physiology, and the pharmacy can produce such a custom-made product to high quality specifications for that patient within minutes. Patients can be either human or animal, as these challenges exist in both human and animal health. The long-term beneficial consequences of the work proposed will include that : (1) patients will attain stable dosage amounts in hours rather than months; (2) challenging patient subpopulations will have available products tailor-made to their metabolism; (3) known life-saving drugs which hitherto could not be commercialized because of severe shelf life limitations can become viable; and (4) both personalized medicine and pharmaceutical product supply chain will be transformed.This I-Corps project enables personalized medicine. The technology is analogous to an inkjet printer, printing precise quantities of medicine on substrates such as tablets and capsules. Our past research has proven precision printing to be well-matched to pharmaceutical production applications. High-precision microfluidics and process analytical technology have been used to validate both the quantity and quality of pharmaceutical products made by printing, and the proof of concept is well-established. Precision of better than 1% relative standard deviation at the stringent individual dose level is routinely achieved. This project will cause broader adoption of precision production, additive manufacturing, just-in-time production, applied microfluidics, and advanced process management.