Takara Bio granted manufacturing license from the Swedish Medical Product Agency for clinical-grade human embryonic stem cell line derivation and banking
Mountain View, CA—July 25, 2018—Takara Bio announced today that 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, 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 says, "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."
For more information about Cellartis Clinical-Grade hES Cell Line Derivation, please visit https://www.takarabio.com/services-and-support/instrument-and-reagent-services/stem-cell-services.
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About Takara Bio
The Takara Bio Group of companies is committed to improving the human condition through biotechnology. It is led by Takara Bio Inc. which represents the biomedical business interests of its parent company, Takara Holdings Inc. The Takara Bio companies support the life science market through the Takara, Clontech, and Cellartis brands, with the Cellartis brand focusing on stem cell-derived products and services for drug discovery, disease modeling, and applications within regenerative medicine. Learn more about Takara Bio at takara-bio.com (Japanese) and takarabio.com (English).
Lorna Neilson, Ph.D.
VP, Corporate Development, Takara Bio USA, Inc.
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