Global biotechnology company, Shire, has received approval from the US Food and Drug Administration (FDA) for its first submission of its new plasma manufacturing facility near Covington, Georgia, where Gammagard Liquid will be produced.
FDA approved
This new facility will add nearly 30% capacity to the company’s internal plasma manufacturing network once fully operational. Commercial production of Gammagard Liquid — [Immune Globulin Infusion (Human)] 10% Solution, a replacement therapy for primary humoral immunodeficiency (PI) — at the site began at the start of the year (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 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.”
“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,” added 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 that a second submission to the FDA for development of its albumin therapy at the facility will be made this year. This albumin therapy is primarily used as a plasma-volume replacement therapy in immune disorders, trauma and other critical conditions.