In July of 2018, Takara Bio announced that the Medical Products Agency (“MPA”), the Swedish national authority responsible for regulation of drug and medical products, had granted the company a manufacturing license for derivation and banking of human embryonic stem (hES) cells to be produced under GMP conditions. The cells were to be produced at Takara Bio’s manufacturing laboratory located in Göteborg, Sweden, within Takara Bio Europe’s facility.

This announcement made Takara Bio the first company worldwide to offer this service for human ESCs.

Takara Bio’s Role with Human Pluripotent Stem Cells

The significance of this event is that Takara Bio is capable of providing a predictable and reliable source of hES cells for future cellular therapeutic development by sourcing starting material from FDA-compliant facilities, according to FDA guidelines and leveraging its proprietary, feeder-free hES cell establishment method, which is animal- and human-component free. [Read more…]