Shire Files for FDA Approval for New Plasma Manufacturing Facility
Shire has filed for approval with the US Food and Drug Administration (FDA) for a new plasma manufacturing facility in Covington, Georgia.
The facility, which will support the company’s growing immunology franchise, is expected to add approximately 30% capacity to the company’s internal network once fully operational. Commercial production is expected to begin in 2018.
The first submission to the FDA at the new facility is for the transfer of Gammagard Liquid (immune globulin infusion, human) 10% solution, a replacement therapy for primary humoral immunodeficiency. 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.
The Covington, Georgia site currently employs approximately 900 full-time employees and contract employees. At the site, Shire plans to ramp up hiring in 2018 to fill roles in manufacturing, quality, engineering, maintenance, utilities, warehouse, and a variety of support and facility roles.
Shire says it also expects to continue expansion of its plasma collection network in Georgia and throughout the US through its subsidiary, BioLife Plasma Services. BioLife collects the human plasma that will be processed into the drugs manufactured at Shire’s new Covington, Georgia facility.