US-based integrated development and manufacturing organisation (IDMO) Cellares, in partnership with Japanese real estate developer Mitsui Fudosan, has established Japan’s first Smart Factory for commercial-scale cell therapy manufacturing.
Located in Kashiwa City, Chiba Prefecture, the facility aims to address the urgent need for scalable and cost-effective CAR-T cell therapies in Japan and neighbouring regions.
The new facility will use Cellares’ advanced technology platforms, Cell Shuttle and Cell Q, to automate manufacturing and quality control processes.
It is expected to reduce batch prices by up to 50% and eliminate manufacturing bottlenecks associated with conventional manual processes.
Cellares CEO and co-founder Fabian Gerlinghaus said: “Cellares’ new facility in Kashiwa City will enable our pharma clients to supply Japan from Japan. Manufacturing cell therapies locally simplifies cold chain logistics, accelerates vein-to-vein time and reduces cost.
“Our Japanese IDMO Smart Factory is part of a broader strategy to be a global manufacturing partner for our clients and meet the total patient demand for cell therapies around the world.”
The Smart Factory will be fully integrated and optimised to prevent downstream bottlenecks.
It is anticipated to enhance the availability of CAR-T treatments and advance the development and approval of CAR-T therapeutics in Japan.
The software-enabled technical transfers between Cellares facilities worldwide will be facilitated by fully automated processes on standardised technologies.
Cellares said that Mitsui Fudosan’s extensive network in Japan’s life sciences industry has played a crucial role in this collaboration.
The real estate developer ensured effective communication with the pharmaceutical industry, government agencies, and the broader healthcare community.
Kashiwa-no-ha Life Science Committee chairperson Toshihiko Doi said: “For cancer patients in Japan, the establishment of this facility provides access to cutting-edge therapies that can make a critical difference in their fight against diseases.
“It marks a significant step toward eliminating the drug delivery lag time that has been a challenge for rare disease and oncology treatments.”
