The US Food and Drug Administration (FDA) has approved Shire’s submission for its new plasma manufacturing facility near Covington, Georgia for producing Gammagard Liquid [immune globulin infusion (human)] 10% Solution, a replacement therapy for primary humoral immunodeficiency.

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 says it expects to distribute product shortly.

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 said it also plans to expand its plasma-collection network in Georgia and throughout the US through its subsidiary, BioLife Plasma Services. BioLife collects the human plasma used in the manufacturing process for immunology products at the Covington facility.

The Covington site currently employs approximately 900 full-time workers and contract employees. Since the beginning of 2018, Shire has been hiring to fill roles in manufacturing, quality, engineering, maintenance, utilities, warehouse, and various support and facility roles.

On a larger scale, Shire is in the process of being acquired by Takeda Pharmaceutical Company for approximately $62 billion. The companies announced in May 2018 that they had come to terms for a deal, which has been approved by both companies’ boards of directors. The transaction is subject to the approval of Shire and Takeda shareholders and certain customary closing conditions, including regulatory approvals.

Source: Shire