Shire seeks US FDA OK to make first med at Covington
Ireland-domiciled Shire announced it had sought agency permission to produce Gammagard Liquid – a plasma-derived antibody product used to treat primary humoral immunodeficiency (PI) - last month.
Matt Walker, head of technical operations for Shire, said, “We are pleased to have filed the Georgia site and look forward to working with the FDA to seek approval for manufacturing in 2018.”
The firm also announced its intention to seek permission to make a second product this year.
Shire acquired the Covington facility when it bought Baxalta in 2016.
In a subsequent US Securities and Exchange Commission (SEC) filing, the firm stated the facility would support growth of its plasma-based treatments.
At present, Shire employs 900 people in Covington. However, the firm said it intends to “ramp up hiring in 2018 to fill roles in manufacturing, quality, engineering, maintenance, utilities, warehouse and a variety of support and facility roles.”
In addition, Shire said that its subsidiary BioLife Plasma Services would further expand its plasma collection network in Georgia and throughout the US.