Shire applies for approval for new US manufacturing site

Shire has filed for US regulatory approval for a new manufacturing facility in Covington, Georgia that will support the growth of its immunology franchise.

A submission has been registered with the US Food and Drug Administration for the new plasma manufacturing site, which is expected to add approximately 30 percent to the company's internal network capacity once fully operational.

Commercial production is expected to begin in 2018, with new manufacturing, quality, engineering, maintenance, utilities and warehouse jobs to be created, in addition to a variety of support and facility roles.

The new regulatory submission pertains to the transfer of manufacturing activities for Gammagard Liquid, a replacement therapy for primary humoral immunodeficiency. A second submission is expected later in 2018 for Shire's albumin therapy, which is primarily used as plasma-volume replacement therapy for various 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."

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