Sumitomo’s CDMO to double regenerative medicine manufacturing capacity

Sumitomo Chemical’s subsidiary S-RACMO, a contract development and manufacturing organization (CDMO) specializing in regenerative medicine and cell therapy, has completed construction of its third manufacturing facility, known as the Center for Regenerative Medicine and Future Therapy (CRAFT). The new addition reportedly will double the company’s production capacity. A fourth facility is already in the planning stages.

Located alongside its two existing facilities, SMaRT and FORCE, the new CRAFT site is designed to strengthen S-RACMO’s manufacturing organization to meet growing demand from customers in Japan and overseas developing regenerative medicine and cell therapies. The campus benefits from proximity to Osaka International Airport and Kansai International Airport, enabling rapid shipment of products both domestically and internationally, said S-RACMO in a press statement.

S-RACMO currently manufactures a range of products, including iPS cells, somatic cells, and somatic stem cells, for both autologous and allogeneic applications under contract for clinical trials, non-clinical use, and commercial supply. The CRAFT facility incorporates design improvements based on the company’s multi-site operational experience and will operate to the latest GCTP and cGMP standards, according to the company.

The expansion is supported in part by Japan’s Ministry of Economy, Trade and Industry via its 2024 Supplementary Budget Subsidies for Regenerative Medicine, Cell Therapies, and Gene Therapy manufacturing equipment. S-RACMO plans to invest an additional 15 billion yen (approximately USD $104 million) to further boost capacity, add production and testing equipment, and build its fourth facility.

As part of its growth strategy, S-RACMO will also manufacture allogeneic iPS cell–derived dopaminergic progenitor cells for Parkinson’s disease, developed by fellow Sumitomo Group company RACTHERA. Sumitomo Pharma and RACTHERA have already submitted a marketing application for the therapy in Japan, and RACTHERA’s manufacturing system is set for expansion under S-RACMO’s initiative.