In regenerative medicine, cell culture is a core manufacturing technology. Because it falls under medical practice, legal compliance is required from production through clinical use. However, the applicable regulations vary depending on the cell type, manufacturing method, and intended application.

“Specified Cell Culture Processing” refers to cell manufacturing conducted at commissioned facilities outside medical institutions, following the procedures and requirements set forth under the Act on the Safety of Regenerative Medicine, which came into effect in November 2014. In practice, adipose-derived stem cell culture processing is most commonly performed under contract with medical institutions.

Under this Act, “regenerative medicine, etc.” refers to medical technologies that utilize cell-based products, excluding blood transfusion, hematopoietic stem cell transplantation, and assisted reproductive technologies.