Takeda’s plasma manufacturing facility approved by FDA
Takeda’s acquired plasma manufacturing plant located near Covington, Georgia, was approved by the US Food and Drug Administration (FDA) for the production of flexbumin (albumin (human)) 25% solution.
The approved facility will provide additional capacity to meet increasing global demand for plasma-derived therapies, according to Takeda. Additional scale up of production will occur at the plant over the next few years.
Takeda acquired Shire in December 2018, after which Takeda created a business unit to meet the global demand for plasma-derived products. “Our strategic focus and increased investment in plasma innovation will enable us to expand,” a spokesperson for Takeda told us.
Before being acquired by Takeda, Shire filed an FDA submission to manufacture the plasma-volume replacement therapy, flexbumin, at its $1.2bn (€1bn) plant in October 2018.
In June 2018, the FDA approved the Georgia facility for the production of gammagard liquid (immune globulin infusion (human)) 10% solution. Shire sought FDA approval to manufacture at the facility in January 2018.
The Georgia facility currently employs approximately 1,000 full-time and contract employees, it will look to hire further staff to fill additional roles at the plant.
