Shire Gets FDA Approval for Plasma Mfg. Facility

The U.S. Food and Drug Administration (FDA) has approved Shire’s first submission for its new plasma manufacturing facility near Covington, GA, for the production of Gammagard Liquid [Immune Globulin Infusion (Human)] 10% Solution, a replacement therapy for primary humoral immunodeficiency (PI).

The Covington facility will add approximately 30% 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.
                 
“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, 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.”

In 2017, Shire’s immunoglobulin portfolio delivered significant growth, with product sales increasing +18% versus prior year. In the first quarter of 2018, Shire’s immunoglobulin portfolio grew +12% 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 Boyle, president and chief executive officer 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.”

The Covington site currently employs approximately 900 full-time employees 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.

Shire also plans to continue expanding its plasma collection network in Georgia and throughout the U.S. through its subsidiary, BioLife Plasma Services. BioLife collects the human plasma used in the manufacturing process for immunology products at the Covington facility.