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.
