Despite significant advances over several decades, very few Tissue Engineered Medical Products (TEMPs) have been clinically or commercially successful. There is a growing need for TEMPs in multiple applications, but a significant technology gap, known as the “Valley of Death”, has prevented their scalable, consistent and cost-effective manufacture. We therefore believe that now is the time for a bold shift from the “Case Center for Multimodal Evaluation of Engineered Cartilage” with its focus on cartilage-centric evaluation technologies to instead develop, demonstrate, and deploy novel technologies to enable Quality-by-Design manufacturing of a variety of structural tissues, and to, thus, bridge the aforementioned Valley of Death.

Our objective is now to promote the adoption of our technologies by the TEMP community at large. Consequently, the center will be renamed “Center for Modular Manufacturing of Structural Tissues” (CM2OST), and will apply knowledge and technology developed during the center's first five years to manufacturing-oriented challenges. 

CM2OST will be a consortium between Case Western Reserve University and the Advanced Regenerative Manufacturing Institute (ARMI), and will focus on technologies that enable scalable, modular, automated, closed (SMAC) manufacturing. The specific aims of the proposal are to: 

  1. Assist our Collaborative Projects and Service Projects by pushing the technologies developed by the Center's four Technology Research and Development Projects (TR&Ds) out to them. 
  2. Through our TR&Ds, develop a cohesive set of innovative technologies, methods, and protocols that enable structural tissue manufacturing, and 
  3. Develop a new, state-of-the-art, training and dissemination program. The center focuses on growing the tissue manufacturing community by offering a series of education and training programs, and resources to help promote our technologies. This center will be a national and international resource for the biomedical community and a platform to establish collaborative efforts towards structural tissue manufacturing applications.