Takara Bio announced that the Medical Products Agency, the Swedish national authority responsible for regulation and surveillance of the development, manufacturing and marketing of drug and other medical products, granted 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 Inc. has been offering world-class gene and cellular therapy manufacturing and operation as a CDMO (Contract Development and Manufacturing Organization) business 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.
Hiroki Tomohisa, CEO, at Takara Bio Europe commented:
“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. 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.”
Takara Bio, an innovative biotechnology company based in Japan, researches and develops reagents for genome engineering and analysis, technology used for gene therapy, and natural health food products using mushrooms and seaweed body and extracts.