The wholly owned subsidiary of Showa Denko Materials (formerly Hitachi Chemical) will build a new facility on its existing site in Ottobrunn, near Munich in Germany, at a total cost of $40.7 million. The plant will be dedicated to clinical and commercial manufacturing as well as development services for cell and gene therapies, operating according to US and European GMP standards.

The investment will more than double Minaris’ existing capacity in Europe by providing additional clean rooms, quality control laboratories, warehousing, cryo-storage and office space.

With a modular design, the facility will have the flexibility to shift between grade B and grade C configuration. It is expected to be operational in early 2023 and will also allow for additional expansion of clean rooms according to customer demand and specifications, more than tripling current clean room capacity.

In Japan, $23.8 million will be spent on establishing another facility adjacent to existing operations in Yokohama, doubling capacity for the commercial manufacture of regenerative medicines. The plant is scheduled to start operations in October 2022. Minaris said this investment is part of a strategy to set up a center for cancer immunotherapy and somatic stem cells.

The expansions complement the opening of a commercial facility in Allendale, New Jersey, USA, in January this year.

Minaris, formerly the regenerative medicine business of Hitachi Chemical, was renamed on Sep. 23, 2020, consolidating the businesses in Germany, North America and Japan under one brand. The German arm was formerly known as apceth Biopharma, while the North American subsidiary was known as Hitachi Chemical Advanced Therapeutics Solutions.

Kazuchika Furuishi, corporate officer and general manager for Hitachi Chemical’s regenerative medicine business and CEO of Minaris, said the move was designed to strengthen the CDMO’s brand perception and recognition as a unified, global organization.

Author: Elaine Burridge, Freelance Journalist