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The company will undertake the manufacturing of clinical material for Bone Therapeutics’ drug, ALLOB
Catalent has signed 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, Belgium. The transaction is expected to close in November.
Under the terms of the agreement, Catalent will purchase the shares of Skeletal Cell Therapy Support, currently held by Bone Therapeutics, which owns and operates a purpose-built CGxP facility of approximately 41,000 square feet, 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 cell therapy capabilities and advanced clinical and commercial supply. Catalent is continuing work on a 60,000-square-foot 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, manufacturing employees located in Gosselies and employed by Skeletal Cell Therapy Support are expected to remain with that entity and become part of the Catalent workforce, and Bone Therapeutics will continue to focus on its pipeline of products for orthopedics and bone diseases.
In addition to the expansion in Gosselies, validation of Catalent’s new 32,000-square-foot cell therapy development facility in Houston, TX is underway and scheduled to be completed by the end of this year.
Bone Therapeutics 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 orthopedic conditions, targeting markets with large unmet medical needs and limited innovation.
Catalent, based in Somerset, NJ, provides delivery technologies, development, and manufacturing services for drugs, biologics, cell and gene therapies, and consumer health products. Catalent employs approximately 14,000 workers, including roughly 2,400 scientists and technicians, at more than45facilities, and in fiscal year 2020 generated more than $3 billion in annual revenue.