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Shire applies for FDA approval on second line
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SOCIAL CIRCLE, Ga. — Shire PLC has applied for government approval to make a second product at its Walton County plasma plant.

The Irish company, a global leader in fighting rare diseases, said Thursday it’s asked the Food and Drug Administration for approval to make Flexbumin 25% Solution, an albumin product primarily used as plasma-volume replacement therapy in immune disorders, trauma and other critical conditions.

The plant in the Stanton Springs development received its first FDA approval, to make immunoglobulin product, earlier this year and officially opened Oct. 11 with about 900 full-time and contract workers.

“We are very pleased to file this second submission for our state-of-the-art manufacturing facility in Georgia, after the facility received FDA approval earlier this year,” Matt Walker, head of technical operations for Shire, said in a statement.

“Expanding our capacity for manufacturing Flexbumin will allow us to better meet the increasing global demand for plasma protein therapies and further supports our growing immunoglobulin and biotherapeutics portfolio by enabling us to deliver these important treatments to our patients.”

The FDA first approved Shire to make albumin product in 2005.

With its new plant in Stanton Springs, Shire increased its capacity to produce plasma-based therapies by 30 percent annually.

Shire is expected to employ about 1,500 people in Georgia by the time production is fully operational at its campus, which covers more than 1 million square feet.