BREAKING NEWS: FDA Approves Shire’s Stanton Springs Facility to Produce GAMMAGARD LIQUID

Dianne Yost Front Page

 

 

Today, Shire (NASDAQ: SHPG) received approval from the Food and Drug Administration (FDA) for the company’s first submission for its new plasma manufacturing facility for the production of GAMMAGARD LIQUID [Immune Globulin Infusion (Human)], which is located at Stanton Springs, a five-county industrial site designed for data centers, advanced manufacturing and bio-pharmaceutical facilities.

 

The facility is located in the Newton County area of Stanton Springs, which also is comprised of land from four other counties including Morgan, Jasper and Walton counties.

 

GAMMAGARD LIQUID is a replacement therapy for primary humoral immunodeficiency.

 

The FDA’s announcement paves the way for Shire to add 30 percent capacity to its internal plasma manufacturing network and strengthens the company’s ability to deliver complex therapies for rare immune-mediated conditions.

 

According to the press release, the commercial production at the site began in January of this year and Shire plans to distribute product shortly.

“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 Covington site currently 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.

“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.”

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.

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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