Shire plc has filed its first submission to the U.S. FDA for the company’s new plasma manufacturing facility in Covington, GA. The facility will expand capacity by approximately 30% once fully operational. Commercial production is expected to begin in 2018.

The submission is for the transfer of GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% Solution, a replacement therapy for primary humoral immunodeficiency (PI). The company expects to make a second submission to the FDA in 2018 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 Covington site currently employs approximately 900 full-time and contract employees. The company plans to begin hiring in 2018 to fill roles in manufacturing, quality, engineering, maintenance, utilities, warehouse and other support and facility roles. 

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