Trizell’s therapeutic is an advanced therapy medicinal product (ATMP) and uses regulatory macrophages (Mregs), a platform technology developed in Germany. Initial development work will take place at the University Medical Center Schleswig Holstein (UKSH), Department of Anesthesiology and Intensive Care Medicine, the Clinic for Applied Cellular Medicine, and the Department of Cardiovascular Surgery, in collaboration with Catalent. CGMP manufacturing of the cell therapy will take place at Catalent’s facility in Gosselies, Belgium.
“This is an important milestone for Trizell and the therapy for the treatment of macro- and microangiopathies,” said Sibille Engels, chief executive officer, Trizell GmbH. “I am delighted to enter into this collaboration with Catalent and to benefit from its outstanding expertise in cell and gene therapy manufacturing.”
Manja Boerman, president, cell and gene therapy, Catalent, said, “Our relationship with Trizell will build on Catalent’s deep knowledge in immunotherapies, from the diagnosis and de-risk stage all the way through to commercial-ready processes. Extending into areas such as macrophages, allows us to stay on the forefront of emerging indications and cell types. The process development, manufacturing expertise, and the experienced production teams we have at Gosselies will enable a faster transition from development to manufacturing.”
Catalent’s 25,000 square-foot (2,300 square-meter) facility in Gosselies, Belgium, provides development and clinical GMP manufacturing services, and construction is in progress on a dedicated 60,000 square-foot (5,574 square-meter) adjacent commercial-scale production and fill-finish facility, which is scheduled to open in 2022. In October 2020, Catalent announced an agreement with Bone Therapeutics to acquire its cell therapy manufacturing subsidiary, Skeletal Cell Therapy Support SA, including all of its assets located in Gosselies, which includes a purpose-built 41,000 square-foot (3,800 square-meter) CGxP development and GMP manufacturing facility next to the existing Catalent facility.