Shire plc made an initial application seeking approval for a new plasma manufacturing facility in Covington, Ga., from the U.S. Food and Drug Administration.
The site already employs 900 full-time and contract employees and is expected to add approximately 30% capacity to the company's internal network once the plasma facility is fully operational.
The Irish-headquartered company made the first submission for the transfer of Gammagard Liquid, a replacement therapy for primary humoral immunodeficiency.
The company will 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.
Shire expects to continue the expansion of its plasma collection network in the U.S. through its subsidiary BioLife Plasma Services LP.
BioLife collects the human plasma that will be processed into the drugs manufactured at Shire's new Covington, Ga., facility.