I-Corps: Transforming Personalized Medicine With Printed Medicine

这个i-Corps项目的更广泛的影响/商业潜力是彻底改变个性化医疗。在复方药房或医院临床药房使用这项技术，可以为患者开出限量的一次性药物组合，为他们的个人生理量身定做，药房可以在几分钟内为该患者生产高质量规格的定制产品。患者可以是人也可以是动物，因为这些挑战在人类和动物健康中都存在。拟议工作的长期有益结果将包括：(1)患者将在几小时而不是几个月内获得稳定的剂量；(2)具有挑战性的患者亚群将拥有为他们的新陈代谢量身定做的可用产品；(3)由于严格的保质期限制而无法商业化的已知救命药物将成为可行的；(4)个性化药物和药品供应链都将发生变化。这一i-Corps项目使个性化药物成为可能。这项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，精密印刷非常适合制药生产应用。高精度的微流控技术和过程分析技术已被用于验证印刷生产的药品的数量和质量，并且概念验证是确凿的。在严格的个人剂量水平上，精密度通常优于1%的相对标准偏差。该项目将使精密生产、添加制造、准时生产、应用微流体和先进工艺管理得到更广泛的采用。

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.