Flexbumin 25% [albumin (human)], USP, 25% solution is primarily used as a plasma-volume replacement therapy in patients with immune disorders, trauma, and other critical conditions.
If Shire’s submission is accepted, the company will manufacture Flexbumin at its $1.2bn, one million-square-foot, immune globulin infusion-producing facility near Covington, Georgia.
According to Shire’s head of technical operations, Matt Walker, expanding manufacturing capacity for Flexbumin will enable the company to meet increasing demand for plasma protein therapies.
In addition, the expansion “further supports our growing immunoglobulin and bio-therapeutics portfolio by enabling us to deliver these important treatments to our patients,” he said in a statement.
The file submission marks Shire’s second for its Georgia facility this year, after the company sought permission to manufacture Gammagard Liquid [immune globulin infusion (human)] 10% solution in January.
The liquid solution, which contains immunoglobulin G antibodies, replaces missing antibodies in patients with primary immunodeficiency. The US Food and Drug Administration (FDA) approved Shire’s production request in June 2018.
According to Shire, the firm plans to expand its plasma collection network in Georgia and the US via its subsidiary BioLife Plasma Services, which collects the human plasma used on-site.