Takeda’s plasma manufacturing facility approved by FDA

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/ Iido Frazao)
(Image: Getty/ Iido Frazao)

Related tags: Fda, Manufacturing, Takeda, Shire

US FDA approves Takeda’s acquired plasma manufacturing facility in Georgia, US, for the production of flexbumin 25% solution.

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.

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