Minaris Regenerative Medicine, a leading global contract development and manufacturing organization for cell and gene therapies, wholly owned by Showa Denko Materials Co., Ltd., announced today a total investment of 64.5 million USD to significantly expand its facilities in Europe and Asia.
A new state of the art facility will be built in the proximity of the existing site in Ottobrunn near Munich, Germany with a total investment of 40.7 million USD. The new facility will operate according to GMP standards (FDA and EMA) and be dedicated to clinical and commercial manufacturing as well as development services for cell and gene therapies. The multi-storey building with a total of 6,650 sqm will initially more than double Minaris’ existing capacity in Europe by providing additional clean rooms, quality control laboratories, warehousing, cryo-storage and office space. It will have a modular design with the possibilities to go from single room to ball room design and to flexibly change between grade B and grade C configuration. The new facility is expected to be operational early 2023 and will allow for additional expansion of clean rooms according to client demand and specifications, thus more than tripling the current clean room capacity.
“We are very pleased to expand our capacity to support the growing demand of clients who continue to care for an increasing number of patients in the future”, said Dusan Kosijer, Managing Director of Minaris Regenerative Medicine GmbH.
A new facility will also be established adjacent to the existing facility in Yokohama, Japan allowing for an additional 4,000 sqm which will double the capacity for commercial manufacturing of regenerative medicine. The new facility is scheduled to start operations in October 2022. The investment of 23.8 million USD is part of a strategy to establish a center for cancer immunotherapy and somatic stem cells.
The European and Asian expansions complement the opening of the new commercial facility in Allendale, New Jersey, USA announced in January this year. “Our investment in the facility expansions of all our three regional sites confirms our commitment to contract development and manufacturing for the cell and gene therapy industry”, commented Kazuchika Furuishi, PhD, Corporate Officer and General Manager, Regenerative Medicine Business Sector of Showa Denko Materials Co., Ltd. “Our global offering to our clients with sites in USA, Germany and Japan enables us to advance our clients’ life-saving therapeutics to patients in need around the world.”