Shire files first submission to FDA for new plasma manufacturing facility

Global biotechnology company, Shire, has filed its first submission to the US Food and Drug Administration (FDA) for a new plasma manufacturing facility in Covington, Georgia, to support growth in its immunology franchise.

This first submission included the transfer of GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% Solution, a replacement therapy for primary humoral immunodeficiency (PI). The company will also be making a second submission this year for its albumin therapy, which is primarily used as plasma-volume replacement therapy in immune disorders, trauma and other critical conditions.

“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,” said Matt Walker, head of technical operations for Shire.

The facility is expected to add approximately 30% capacity to the company’s internal network once fully operational. Commercial production is expected to begin in 2018.