Takara Bio Granted Mfg. License From Sweden’s Medical Authority

The Medical Products Agency (MPA), the Swedish national authority responsible for regulation and surveillance of the development, manufacturing and marketing of drug and other medical products, recently granted Takara Bio a manufacturing license for derivation and banking of human embryonic stem (hES) cells to be produced under GMP conditions at the state-of-the-art laboratory located in Göteborg, Sweden, within Takara Bio Europe’s facility.

Since October 2014, Takara Bio has been offering world-class gene and cellular therapy manufacturing and operation as a contract development and manufacturing organization (CDMO) at the Center for Gene and Cell Processing, located in Kusatsu, Japan. The Göteborg facility complements Takara Bio’s global efforts to meet the varied needs of clients in the gene and cellular therapy industries.

“I am pleased that Takara Bio Europe’s long-standing experience in hES cell derivation is offered as a contract manufacturing service under the MPA license,” said Hiroki Tomohisa, chief executive officer, Takara Bio Europe. “We have a proprietary feeder-free hES cell establishment method which is animal- and human-component free. Starting material is retrieved from FDA-compliant sources according to FDA guidelines. This means we are capable of providing a safe, reliable source of hES cells for future cellular therapeutic development for our clients.”