EAGER: Engineering for Regenerative Medicine

EARLY探索性研究资助（EAGER）项目将调查支持再生医学的制造系统的要求。再生医学创造活的功能性组织来修复或取代失去的组织或器官功能。该领域有望通过刺激以前无法修复的器官来修复自己，或者通过在实验室中生长组织和器官以进行安全植入来再生体内受损的组织和器官。重要的是，再生医学有可能解决与需要挽救生命的移植患者数量相比供体器官短缺的问题，以及解决器官移植排斥的问题。初期工作的重点将是将再生组织和器官早期生产中使用的配方和协议转化为制造工程术语和规范。这项早期桥接研究的主要成果将是将为一个特定器官（膀胱）开发的生物和医学要求转化为开发全面制造所需的工程过程定义和资源要求。将开发正式的工程模型，明确定义用于生产组织和器官的生物反应器的资源要求，沿着描述生物反应器内外发生的转化特征的工艺模型。正式模型开发的目的不是简单地绘制用于生产再生产品的当前方法，而是定义发生的基本转换以及尝试识别其制造中使用的资源和工艺方法的早期约束。这些过程模型将成为开发制造系统模型的关键资源，用于再生产品的高效、经济的生产系统。

This EArly Grant for Exploratory Research (EAGER) project will investigate the requirements for manufacturing systems to support regenerative medicine. Regenerative medicine creates living, functional tissues to repair or replace tissue or organ function lost. This field holds the promise of regenerating damaged tissues and organs in the body either by stimulating previously irreparable organs to heal themselves, or by growing tissues and organs in the laboratory for safe implantation. Importantly, regenerative medicine has the potential to solve the problem of the shortage of donor organs compared to the number of patients that require life-saving transplantation, as well as solve the problem of organ transplant rejection.The focus in the initial effort will be to translate the recipes and protocols used in the early production of regenerative tissue and organs into manufacturing engineering terms and specifications. The major result of this early bridging research will be translating the biological and medical requirements that have been developed for one specific organ (bladders) into the kinds of engineering process definitions and resource requirements needed to develop full scale manufacturing. Formal engineering models that will explicitly define the resource requirements for the bioreactors used to produce tissue and organs will be developed, along with process models that characterize the transformations that take place both outside and within the bio-reactors. The intent of the formal model development is not simply to chart the current methods used to produce regenerative products but rather to define the basic transformations that take place as well as to try to identify early constraints on the resources and process methods used in their manufacture. These process models will then become a key resource in developing manufacturing system models for efficient, cost effective production systems for regenerative products.