Shire to scale up workforce after plasma facility wins US FDA approval

By Ben Hargreaves

- Last updated on GMT

Getty/Olivier Le Moal
Getty/Olivier Le Moal
Shire has received US FDA approval to produce gammagard liquid solution at its Covington, Georgia plant.

The decision by the US Food and Drug Administration (FDA) means that Shire now plans to ramp up hiring within the state to manage production at the facility.

Back in 2016, when Shire acquired Baxalta, the former took on the facility and its plans to produce gammagard liquid (immune globulin infusion) 10% solution at the facility. Two years on, the company is now able to distribute the liquid, which contains immunoglobulin G antibodies, replacing missing antibodies in patients with primary immunodeficiency.

A spokesperson for Shire revealed it likely to increase hiring in the state as a result of the approval: “A strong workforce is critical to our ability to develop and deliver life-altering therapies to patients. We expect to eventually employ around 1,500 full-time colleagues in Georgia between the Covington site and our BioLife Plasma Services plasma collection centers.”

The facility itself covers one million-square-feet of space and employs 900 people. The spokesperson revealed how the approval will expand Shire’s global capabilities in fractionation, purification, and filling capacity by approximately 30% – once operations at the facility are completely up-to-speed.

In addition, the spokesperson noted that: “With fractionation, purification and filling at the same plant, Covington has the potential to increase efficiency and speed in the manufacturing process to bring our plasma-derived therapies to patients faster.”

After having been granted FDA approval for its gammagard liquid solutions, the next step for Shire is to expand this to producing albumin therapies. Shire’s spokesperson revealed there are plans to make an official submission to the FDA later this year, though this would make little difference to operations at the facility as the company is already scaling up ready for the increased workload.

Depending on when the Takeda-Shire merger​ completes, it may actually be Takeda that is responsible for submitting the final documentation for further approval.

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