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| Kyowa Hakko Kirin's new API plant in Japan--Courtesy of Kyowa Hakko Kirin |
Japanese drugmaker Kyowa Hakko Kirin (KHK), which develops its own drugs and is in a partnership with Fuji to make biosimilars, has completed construction on a new active pharmaceutical plant for biologics.
The Tokyo-based company said it invested ¥6 billion ($58.8 million) in the four-story, 3,892-square-meter (41,900-square-foot) facility. It has a 12,000-liter bioreactor for recombinant animal cells--which it claims is among the largest in Japan--and a purification system.
The drugmaker said the facility complies with regulations in the U.S. and EU, as well as Japan. It expects it to be approved and ready for operations in the first half of 2016.
KHK in 2011 entered into a partnership with Fuji to pool their expertise, KHK in making biologics and Fuji in low-cost production, to concentrate on the biosimilars market. More recently, Kyowa Hakko Kirin partnered with Novato, CA-based startup Ultragenyx Pharmaceutical to work on KHK's rare bone-disease drug, an antibody designed to treat X-linked hypophosphatemia.
- here's the release