I-Corps: Transforming Personalized Medicine With Printed Medicine

I-Corps项目更广泛的影响/商业潜力是彻底改变个性化医疗。在配药药房或医院临床药房使用这项技术，患者可以根据其个人生理状况定制限量的一次性药物组合，药房可以在几分钟内为该患者生产出高质量规格的定制产品。患者可以是人类也可以是动物，因为这些挑战在人类和动物健康中都存在。所建议的工作的长期有益后果将包括：(1)患者将在数小时而不是数月内获得稳定的剂量；(2)具有挑战性的亚群患者将获得针对其新陈代谢量身定制的产品；(3)迄今为止因严重的保质期限制而无法商业化的已知救生药物变得可行；(4)个性化医疗和医药产品供应链都将发生变革。这个I-Corps项目使个性化医疗成为可能。该技术类似于喷墨打印机，在片剂和胶囊等基材上打印精确数量的药物。我们过去的研究已经证明，精密印刷是很好地匹配制药生产应用。高精度微流体和过程分析技术已被用于验证印刷药品的数量和质量，并且概念验证已经建立。在严格的个体剂量水平下，通常可达到优于1%相对标准偏差的精度。该项目将广泛采用精密生产、增材制造、准时生产、应用微流体和先进的过程管理。

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.