CUTISS’s first onsite manufacturing facility in Schlieren, Zurich, has received the certification of compliance for Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) from the regulator Swissmedic, the Swiss Agency for Therapeutic Products.
The GMP and GDP certifications authorizes the collection, manufacturing, testing, storage, release, and distribution of Transplant Products (TpP), Gene Therapy (GT) and Genetically Modified products (GM) for human use.
This important milestone completes the expansion of CUTISS’ facilities, led by Kathi Mujynya and her Operations team. The state-of-the-art manufacturing facility is fully equipped for the manufacturing and testing of tissue-engineered products, notably for the personalized human skin tissue therapy denovoSkin which is currently in Phase 2 clinical trials.
The facility in Schlieren is expected to become fully operational in Q1-Q2 2022. Until now, the company’s products have been manufactured at the GMP facility of Wyss Zurich Regenerative Medicine Technologies Platform, University of Zurich.