Production Platform for Personalized Tissue-Engineered Transplants

Important results from the project

The rapidly growing and medically important field of advanced tissue engineering is in great need of automated, scalable and secure production processes. The goal has therefore been to develop generic methods, where we have shown that the process works with a few model organs, and to adapt these to clinical standards. As part of the results, we designed different quality tests to be able to release approved high-quality products from this platform. We have successfully completed all activities and reached all milestones of the project.

Expected long term effects

We have established a completely new and generic platform for production of customized tissue engineered grafts and developed an automated production process for upscaling and adapted it to GMP standard. As part of this, an industrial sterilization method and quality assured processes for release of tissue engineering products have been developed. Finally, an important biomechanical quality test has been developed, and technology transfer, from preclinical to clinical GMP production, has been performed with a product that is now entering clinical trials.

Approach and implementation

The tissue engineering production platform that we have developed is generic and can be adapted to virtually any body. In the project, we have mainly worked with arteries, nerves, and an advanced vein product. Our project has been a close collaboration and we have utilized competencies in basic research, industrial development, and routine quality assurance optimally. To reach clinical standards, and to disseminate the results internationally, the technology has been transferred to Lithuania and Spain where GMP production is now ready for clinical trials.