Shire Files for FDA Approval of a New Plasma Manufacturing Facility

Dec 28, 2017
By BioPharm International Editors

On Dec. 27, 2017, Shire announced that it has filed its first FDA submission for the company’s new plasma manufacturing facility in Covington, GA. The facility is expected to add approximately 30% capacity to the company’s internal network once fully operational, with commercial production expected to begin in 2018.

The first submission is for the transfer of Gammagard Liquid [Immune Globulin Infusion (Human)] 10% Solution, a replacement therapy for primary humoral immunodeficiency. According to the company, it expects to make a second submission to FDA in 2018 for its albumin therapy, which is primarily used as plasma-volume replacement therapy in immune disorders, trauma, and other conditions.

“We are pleased to have filed the Georgia site and look forward to working with [FDA] to seek approval for manufacturing in 2018. The additional capacity from this site is a key element to support the growth in our immunology franchise,” said Matt Walker, head of technical operations for Shire, in a company press release.

The Covington, GA, site currently employs approximately 900 employees, and in 2018, the company plans to increase job offerings to meet facility needs. Additionally, the company expects to continue expansion of its plasma collection network in Georgia and throughout the United States through its subsidiary, BioLife Plasma Services, which collects the human plasma that will be processed into the drugs manufactured at the new Covington facility.

Source: Shire

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