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FDA approves Shire’s new drug

Tia Lynn Ivey News

It’s official. Shire’s manufacturing plant in Stanton Springs has earned FDA approval for “GAMMAGARD Liquid,” a medication treating humoral immunodeficiency diseases by infusing patients with immunoglobulin G (IgG) antibodies, which protect the body from various infections.

Shire, a global pharmaceutical company, which specializes in treating rare diseases, built a $1.2 Billion manufacturing plant in Stanton Springs’s Industrial Park in 2015 to produce the new plasma product.

“This is going to be great for our communities,” said Alan Verner, chairman of the Joint Development Authority comprised of Morgan, Walton, Newton, and Jasper counties, which oversees the development of Stanton Springs. “We are definitely glad that they have achieved one of their main goals in a timely fashion. Tax revenues will start up soon now that they have been approved and that is always good for the community. They can also start ramping up jobs more steadily.”

Now that FDA Approval has come through for Shire’s new medicine, Shire will move into the next phase of operations, according to Shire officials.

“The Covington facility will add approximately 30 percent capacity to Shire’s internal plasma manufacturing network once fully operational. Commercial production at the site began in January 2018, and Shire expects to distribute product shortly now that approval has been granted,” explained Gabe Khouli, communications lead for Shire’s plant in Stanton Springs.
“The approval of our Covington, Georgia facility is a significant milestone for Shire and for the patients we serve,” said Matt Walker, Head of Technical Operations for Shire. “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.”

According to Shire officials, in 2017, Shire’s immunoglobulin portfolio delivered significant growth, with product sales increasing 18 percent versus prior year. In the first quarter of 2018, Shire’s immunoglobulin portfolio grew 12 percent driven by continued strong sales of subcutaneous products.

“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,” said John G. Boyle, President and CEO of the Immune Deficiency Foundation. “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.”

According to Khouli, the Stanton Springs plant employs approximately 900 full-time colleagues and contract employees. Since the beginning of 2018, Shire has ramped up hiring to fill roles in manufacturing, quality, engineering, maintenance, utilities, warehouse, and various support and facility roles.

“Shire expects to make a second submission to the FDA in 2018 for development of its albumin therapy at the Covington facility. Shire’s albumin therapy is primarily used as plasma-volume replacement therapy in immune disorders, trauma and other critical conditions,” said Khouli. “Shire also plans to continue expanding its plasma collection network in Georgia and throughout the United States through its subsidiary, BioLife Plasma Services. BioLife collects the human plasma used in the manufacturing process for immunology products at the Covington facility.”

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