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Senior Director, Regenerative & Cellular
Medicine Manufacturing Plant, SMaRT
Sumitomo Dainippon Pharma
Regenerative medicine caught the world’s attention in 2012 when Dr. Shinya Yamanaka, Professor and Director of the Center for iPS Cell Research and Application (CiRA) at Kyoto University, was awarded the Nobel Prize in Physiology or Medicine. With the backing of the Japanese government, research into regenerative medicine, primarily at universities, received a powerful boost.
An important development in this up-and-coming field was the completion in 2018 of Sumitomo Dainippon Manufacturing Plant for Regenerative Medicine and Cell Therapy (SMaRT), the world’s first facility dedicated to the commercial manufacture of regenerative medicine and cell therapy products derived from allogeneic iPS cells. Sumitomo Dainippon Pharma is preparing for commercial production of products for the treatment of Parkinson’s disease, age-related macular degeneration, and retinitis pigmentosa, with sales expected to start in 2022 at the earliest.
Kenji Komeda, Senior Director of the plant, comments on the significance of tackling production of regenerative medicine and cell therapy products: “Regenerative medicine products have already been commercialized to some extent but mainly for autologous transplantation using the patient’s own stem cells, which means they are tailor-made for the individual patient. We aim to provide products for more patients by producing cell therapy products derived from allogeneic iPS cells, that is, by using cells from healthy donors.”
Sumitomo Dainippon Pharma has earned recognition as a world-renowned pioneer in the manufacture of regenerative medicine and cell therapy products by tenaciously promoting research, having focused on regenerative medicine since the 1990s. The company has also cultivated a fruitful network of relationships with academia, including with Nobel Laureate Professor Yamanaka.
“All of us in the team are excited by the prospect of a future in which patients who are unable to recover with conventional medicine can be cured,” says Komeda. They are determined to make this dream come true as soon as possible.
Reprinted from SUMITOMO QUARTERLY NO.162