CUTISS develops a personalized hum skin-graft for the treatment of burns which were manufactured at the GMP facility of Wyss Zurich Regenerative Medicine Technologies Platform, University of Zurich. The spin-off from the University of Zurich (UZH)/University Children’s Hospital has now achieved full independence in its manufacturing capabilities with a state-of-the-art facility, located at the company’s headquarters at the Biotechnopark in Zurich-Schlieren. The onsite facility covers a surface area of 150 square meters and is comprised of several laboratories including a biobank and a histology lab. This follows the certification of compliance for Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) from Swissmedic, the Swiss Agency for Therapeutic Products, in October 2021, and the authorization to transfer the technology from Wyss Zurich to CUTISS.
The startup's facility has commenced manufacturing and testing of tissue-engineered products. “This evolution represents a critical milestone for CUTISS. It centralizes our activities around the manufacturing of denovoSkin, increases our production capacities, and enables us to scale up the manufacturing process and take our automation program to the next level”, said Kathi Mujynya, Chief Operating Officer at CUTISS.
Following the successful transfer of technology, CUTISS has become one of the first regenerative medicine companies to transfer out of this platform at Wyss Zurich. Professor Simon P. Hoerstrup, Founding Co-Director of the Wyss Zurich Translational Center, stated: “We are extremely pleased with the development of the project during its five years at Wyss Zurich, not least because it has all come out of our own development at the University of Zurich, our state-of-the-art technical and scientific platform facilities, and the Children’s Hospital Zurich. Starting as a research project, moving to preclinical implementation, and finally to clinical trials in a highly regulated environment – this is one of Wyss Zurich’s flagship projects.”
Daniela Marino, Chief Executive Officer at CUTISS, commented: “We are very grateful to Wyss Zurich for their help and support throughout the last five years, enabling CUTISS to grow and arrive at this stage of development. Now, we are thrilled to have established and launched our own independent manufacturing capabilities, enabling us to scale up the development of our personalized skin tissue therapy and to meet the needs of patients with severe skin injuries.”