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.
This project focused on specifying biological processes using engineering formalisms and resulted in valuable findings -- many that resulted from bringing engineers and medical researchers together. First, many of the problems associated with biological variability are due to biological protocols that leave many of the details associated with a practice to the technician. We found that much of the variability associated with outcomes was due to differences in technician practice rather than the actual biology of the cells. Several major improvements to processes used for producing biologics have resulted from this work. Next, there is a broad set of applications for engineers in the world of medicine. For instance, one of the outcomes for this project was the development of a "Tissue Expander" -- a device that can be used to mechanically stretch tissue to stimulate growth of the tissue. The application for the process that we explored was that of Skin stretching so that skin harvested fron a burn or trauma patient can be expanded to cover a wound area of twice the size of that taken. The device that we created should change many of the practices associated with mechanically growing tissue. A patent has been filed for the device and we are continuing operational testing to try to bring this system in medical practice.