- Source : Press Release
- Date : 2021-02-08
- Event type : Phase 1
- Companies : Catalent, Inc.
Catalent Signs Development and Manufacturing Agreement with Trizell for Macrophage-Based Advanced Cell Therapy
SOMERSET, N.J. – February 8, 2021 — Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that it had signed an agreement with Trizell GmbH, to support the manufacturing of Trizell's Phase 1 cell therapy for the treatment of micro- and macroangiopathies.
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, Ph.D., 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.”
“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,” commented Manja Boerman, Ph.D., President, Catalent Cell & Gene Therapy. “Extending into areas such as macrophages, allows us to stay on the forefront of emerging indications and cell types.” She added, “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.
ABOUT CATALENT CELL & GENE THERAPY
With deep experience in viral vector scale-up and production, Catalent Cell & Gene Therapy is a full-service partner for adeno-associated virus (AAV) and lentiviral vectors, and CAR-T immunotherapies. When it acquired MaSTherCell, Catalent added expertise in autologous and allogeneic cell therapy development and manufacturing to position it as a premier technology, development and manufacturing partner for innovators across the entire field of advanced biotherapeutics. Catalent has a global cell and gene therapy network of dedicated, large-scale clinical and commercial manufacturing facilities, and fill-finish and packaging capabilities located in both the U.S. and Europe. An experienced partner, Catalent Cell & Gene Therapy has worked with industry leaders across 70+ clinical and commercial programs.
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs approximately 15,000 people including around 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com
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ABOUT TRIZELL GMBH
Trizell GmbH is a German biotech company and a subsidiary of Trizell Holding SA in Switzerland. Trizell focuses on the research, development, production and distribution of innovative pharmaceutical and diagnostic products in particular in the field of gene therapy and cell therapy.