Under the terms of the agreement, Catalent has purchased the shares of SCTS, previously held by Bone Therapeutics, and a purpose-built CGxP facility of approximately 41,000 square-foot (3,800 square-meter), including its related quality control and product development laboratories, warehouse, grade C and B cleanrooms and equipment as well as land for further development. Catalent will undertake the manufacturing of clinical material for Bone Therapeutics’ drug, ALLOB, an allogeneic osteoblastic cell therapy product, derived from ex vivo cultured bone marrow cells.
The Bone Therapeutics subsidiary and its facility, which is next to Catalent’s existing cell therapy site, will allow Catalent to expand its industry-leading cell therapy capabilities and advanced clinical and commercial supply, and create an integrated European center of excellence in cell therapy. Catalent is continuing work on its dedicated 60,000 square-foot (5,574 square-meter) commercial-scale production and fill-finish facility in Gosselies, which is scheduled to be completed by the end of 2021.
As part of the acquisition, all of the experienced manufacturing employees located in Gosselies and employed by SCTS will remain with SCTS and become part of the Catalent workforce, and Bone Therapeutics will continue to focus on its pipeline of unique, innovative products addressing high unmet medical needs in the fields of orthopedics and bone diseases.
“Catalent is committed to supporting the development and manufacture of next-generation therapies and bringing life-changing treatments to patients in need,” commented Manja Boerman, Ph.D., President, Catalent Cell & Gene Therapy. “Following the acquisition of MaSTherCell, the additional manufacturing capacity and technical expertise that this deal with Bone Therapeutics gives us will immediately expand our functional clinical and commercial capacity for current late-stage customers. This addition also creates a strong center of cell therapy excellence for Catalent in Europe and will serve as a hub for the growing cell therapy pipeline.”
“This agreement with Catalent is an important strategic step for Bone Therapeutics and is the result of our continuous effort to optimize our operations,” said Miguel Forte, CEO, Bone Therapeutics. “The integration of our manufacturing subsidiary into Catalent, one of the premier contract manufacturers in the cell therapy space, significantly increases our operational flexibility. It enables Bone Therapeutics to maximize the efficient use of our manufacturing assets by combining the manufacturing facility and specialist operators with Catalent’s global network of clinical and commercial manufacturing facilities. This will ensure the most efficient ongoing global production of ALLOB. It also allows us to further focus on our core activity: developing innovative cell-based treatments for conditions with high unmet medical needs. This deal will facilitate our efforts to bring ALLOB more quickly within the reach of patients around the world.”
In addition to the expansion in Gosselies, validation of Catalent’s new 32,000 square-foot (3,000 square-meter) cell therapy development facility in Houston, Texas is underway and scheduled to be completed by the end of 2020.
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 14,000 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 BONE THERAPEUTICS
Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and other diseases. The Company has a, diversified portfolio of cell and biologic therapies at different stages ranging from pre-clinical programs in immunomodulation to mid-to-late stage clinical development for orthopaedic conditions, targeting markets with large unmet medical needs and limited innovation.