I-Corps: Transforming Personalized Medicine With Printed Medicine

I-Corps:通过印刷医学改变个性化医疗

基本信息

  • 批准号:
    1644609
  • 负责人:
  • 金额:
    $ 5万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
    Standard Grant
  • 财政年份:
    2016
  • 资助国家:
    美国
  • 起止时间:
    2016-08-01 至 2017-06-30
  • 项目状态:
    已结题

项目摘要

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.
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。

项目成果

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Gintaras Reklaitis其他文献

Bayesian statistical approaches to drug product variability assessment and release
贝叶斯统计方法在药品变异评估和放行中的应用
  • DOI:
    10.1016/j.ijpharm.2022.122037
  • 发表时间:
    2022-08-25
  • 期刊:
  • 影响因子:
    5.200
  • 作者:
    Qing Cai;Linas Mockus;David LeBlond;Xu Sun;Hui Wei;Harsh S. Shah;Kaushalendra Chaturvedi;Rusha Sardhara;Kajalajit Nahar;Rania Khalil;Amit Sharma;Dave Rutesh;Girish Joglekar;Gintaras Reklaitis;Kenneth Morris
  • 通讯作者:
    Kenneth Morris
A hybrid system for design space estimation in a rotary tablet press
一种用于旋转式压片机设计空间估计的混合系统
  • DOI:
    10.1016/j.ijpharm.2025.125663
  • 发表时间:
    2025-06-10
  • 期刊:
  • 影响因子:
    5.200
  • 作者:
    Mohammad Shahab;Sunidhi Bachawala;Marcial Gonzalez;Zoltan Nagy;Gintaras Reklaitis
  • 通讯作者:
    Gintaras Reklaitis

Gintaras Reklaitis的其他文献

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{{ truncateString('Gintaras Reklaitis', 18)}}的其他基金

Conference: Accelerating Drug Product Development and Approval: A Critical Need in Response to National Emergencies
会议:加速药品开发和审批:应对国家紧急情况的迫切需要
  • 批准号:
    2232197
  • 财政年份:
    2023
  • 资助金额:
    $ 5万
  • 项目类别:
    Standard Grant
CDI-Type II: Cyber-enabled engineering of pharmaceutical products
CDI-Type II:医药产品的网络工程
  • 批准号:
    0941302
  • 财政年份:
    2009
  • 资助金额:
    $ 5万
  • 项目类别:
    Standard Grant
Engineering Virtual Organization for Pharmaceutical Engineering and Science
制药工程与科学工程虚拟组织
  • 批准号:
    0742760
  • 财政年份:
    2007
  • 资助金额:
    $ 5万
  • 项目类别:
    Continuing Grant
International Travel Grant for Participants in Process Systems; January 5-10, 2004; Kunming, China
为流程系统参与者提供国际旅行补助金;
  • 批准号:
    0403304
  • 财政年份:
    2003
  • 资助金额:
    $ 5万
  • 项目类别:
    Standard Grant
An Intergrated Approach to Environmentally Conscious Paper Mill Operations
环保造纸厂运营的综合方法
  • 批准号:
    9729782
  • 财政年份:
    1997
  • 资助金额:
    $ 5万
  • 项目类别:
    Continuing Grant
Travel Grant for U.S. Academic Participants in Workshop on World-Wide Industry-University-Government Research Collaboration Models in the Chemical Sciences & Engineer
为参加全球工业-大学-政府化学科学研究合作模式研讨会的美国学术参与者提供旅费资助
  • 批准号:
    9529532
  • 财政年份:
    1996
  • 资助金额:
    $ 5万
  • 项目类别:
    Standard Grant
Renovation of Advanced Materials Laboratory in Chemical Engineering
化学工程先进材料实验室改造
  • 批准号:
    9313470
  • 财政年份:
    1994
  • 资助金额:
    $ 5万
  • 项目类别:
    Standard Grant
New Directions in ChE Undergraduate Laboratory Experience
化学工程本科实验室经验的新方向
  • 批准号:
    8951295
  • 财政年份:
    1990
  • 资助金额:
    $ 5万
  • 项目类别:
    Standard Grant
International Travel Grant for Participants in Process Systems Engineering in Sydney, Australia from August 28 - September 2, 1988
为 1988 年 8 月 28 日至 9 月 2 日在澳大利亚悉尼参加过程系统工程参与者提供国际旅行补助金
  • 批准号:
    8815153
  • 财政年份:
    1988
  • 资助金额:
    $ 5万
  • 项目类别:
    Standard Grant
Research Conference Proposal: "Foundations of Computer Aided Process Operations" July 5-10, 1987 - Park City, Utah
研究会议提案:“计算机辅助流程操作的基础” 1987 年 7 月 5 日至 10 日 - 犹他州帕克城
  • 批准号:
    8613432
  • 财政年份:
    1987
  • 资助金额:
    $ 5万
  • 项目类别:
    Standard Grant

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