The cell and gene therapy CDMO will build additional facilities at its German and Japanese locations.
The contract development and manufacturing organization (CDMO) specializing in cell and gene therapies announced two separate investments of $40.7 million (€34.2 million) into its Ottobrunn, Germany, site, and $23.8 million for its Yokohama, Japan, site.
Both regions now come under the umbrella of Minaris Regenerative Medicine, a subsidiary of Showa Denko Materials, after a rebrand in September to unify the name of its three businesses located in North America (previously, Hitachi Chemical Advanced Therapeutics Solutions (HCATS)), Europe (apceth Biopharma), and Japan (Hitachi Chemical).
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The Japanese company acquired apceth last year for $86 million and will now add a 6,650-square-meter facility to the German site. The space will include additional clean rooms, quality control laboratories, warehousing, cryo-storage and office space.
Once operational in 2023, the facility will more than triple the current clean room capacity.
A spokesperson for Minaris explained that the facility will feature a modular design, which allows the company “to combine two smaller units into one large ball room and to shift from a grade B to grade C to grade B environment according to our clients‘ needs.â€
The European site became one of the first CDMOs to manufacture a commercial gene therapy, after agreeing a deal with bluebird bio to manufacture its Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) product last year.
While the company’s Japanese site will also receive an additional facility, which will cover 4,000-square-meters and is scheduled to start operations in October 2022.
The space will be used specifically for the commercial manufacture of regenerative medicine, particularly cancer immunotherapies and somatic stem cells, doubling the site’s existing capacity.
Minaris’ global presence for a cell and gene specialist is unusual for an industry often concentrated in the US. However, the spokesperson for Minaris outlined that a global position confers an “advantage to our clients that are seeking a global manufacturer to produce their product in different regions – for example, clients with autologous cell products that need a manufacturing site close to the patients.â€
Additionally, “We have regulatory expertise in Europe, Japan and the US and can leverage the expertise of one region to another,†the spokesperson added.