Shire files for FDA approval for Georgia plasma manufacturing site

Specialty biopharmaceutical company Shire has filed its first submission to the US Food and Drug Administration for a new plasma manufacturing facility in Covington, Georgia, which is expected to add around 30% capacity to the company’s internal network once fully operational.

The first submission is for the transfer of Gammagard Liquid 10% solution, a replacement therapy for primary humoral immunodeficiency (PI). Shire expects to make a second submission to the FDA next year for its albumin therapy, which is primarily used as plasma-volume replacement therapy in immune disorders, trauma and other critical conditions.

Matt Walker, head of technical operations for Shire, said: “We are pleased to have filed the Georgia site and look forward to working with the FDA to seek approval for manufacturing in 2018. The additional capacity from this site is a key element to support the growth in our Immunology franchise.”

Shire said it has experienced significant growth in Immunology, including a 21% increase in September year-to-date product sales in 2017 on a pro-forma basis.

The Covington, Georgia site currently employs approximately 900 full-time colleagues and contract employees. It plans to ramp up hiring next year to fill roles in manufacturing, quality, engineering, maintenance, utilities, warehouse and a variety of support and facility roles.

Shire also expects to continue expansion of its plasma collection network in Georgia and throughout the US through its subsidiary, BioLife Plasma Services, which collects the human plasma that will be processed into the drugs manufactured at Shire’s new Covington facility.

At 1305 GMT, the shares were up 1% to 3,920.50p.