SOCIAL CIRCLE, Ga. — Shire PLC said it has received approval from the Food and Drug Administration for its massive plasma manufacturing plant in Stanton Springs.The stamp of approval from the federal government will allow Shire to produce Gammagard Liquid immune globulin infusion 10 percent solution, a replacement therapy for primary humoral immunodeficiency.
This story has been updated with comments from Chairman Marcello Banes and Immune Deficiency Foundation CEO John G. Boyle.
The facility will add about 30 percent capacity to Shire’s internal plasma manufacturing network once it’s fully operational.
Newton County Board of Commissioners Chairman Marcello Banes said the FDA’s decision means great things for the local economy.
“We are proud of Shire for reaching this milestone and eager for them to ramp up production and to continue to put people to work and contribute even more to Newton County’s economic growth,” Banes said. “It is a great day for Newton County.”
Commercial production at the site began in January 2018, and Shire expects to distribute product soon, now that it’s received FDA approval.
“The approval for our Covington, Georgia, facility is a significant milestone for Shire and for the patients we serve,” Matt Walker, the head of technical operations for Shire, said in a news release.“The increased manufacturing capacity from the site will support Shire’s growing immunology franchise and further strengthens our ability to deliver complex therapies for patients around the world living with a range of rare and immune-mediated conditions.”
Shire saw significant growth in its immunoglobulin business last year, with product sales increasing 18 percent over the previous year, according to the company.
Sales grew another 12 percent in the first quarter of 2018, driven by the continued strong sales of subcutaneous products, the company said.
“The demand for immunoglobulin continues to accelerate, and we understand that the safe production of these plasma-based therapies is a time-consuming, intricate and highly regulated process,” John G. Boyle, the president and CEO of the Immune Deficiency Foundation, said.
“The fact that even more people with primary immunodeficiency diseases have the potential to be helped, with the approval of a new, cutting-edge manufacturing facility specifically designed to produce complex plasma-based therapies, is welcome news for our patient community.”
Shire has about 900 full-time and contract employees at the Stanton Springs plant, up from about 700 in spring 2017. The company has ramped up hiring since the first of the year in manufacturing, quality, engineering, maintenance, utilities, warehouse and support and facility roles.
Shire’s roots in the area date to 2012 when Gov. Nathan Deal announced Baxter International would make a biopharmaceutical plant the first occupant of Stanton Springs. The master-planned community is owned and managed by a partnership of the Joint Development Authority of Jasper, Morgan, Newton and Walton Counties and Atlanta-based TPA Group.
Baxter later spun off its biopharmaceutical business into a separate company, Baxalta Inc., which Dublin, Ireland-based Shire purchased in 2016.
As part of the state’s incentives package to lure Baxter, the $14 million Georgia BioScience Training Center opened at Stanton Springs in 2015.
Facebook was announced as a new neighbor for Shire in March. The social media giant said it would build a massive data center in Stanton Springs. Construction is already underway.
Shire doesn’t plan to rest on its recent FDA approval. The company already plans to make a second submission, for development of its albumin therapy at the local plant. The albumin therapy is used primarily as a plasma-volume replacement therapy in immune disorders, trauma and other critical conditions.Shire also plans to continue expanding its plasma collection network in Georgia and throughout the U.S.