Shire seeks FDA sign-off on plasma manufacturing facility
- Shire plc has filed for Food and Drug Administration approval of its Covington, Georgia-based plasma manufacturing facility to produce Gammagard Liquid, a replacement therapy for primary humoral immunodeficiency.
- Getting the Covington site up and running will be a boost for the Irish drugmaker, adding 30% capacity to its network for production of plasma products, Shire said in a Dec. 27 statement. The company expects to submit for FDA sign-off for production of its albumin therapy later this year as well.
- Currently, Shire employs 900 staff at the site but will recruit more people this year to fill roles in manufacturing, quality, engineering and other functions.
Behind Shire's expansion of plasma manufacturing is a growing immunology franchise, which recorded a 32% year-over-year increase in the third quarter of 2017.
Divided between immunoglobulin therapies and biotherapuetics, Shire's immmunology business consists of products like Gammagard (immune globulin infusion), Cuvitru (immune globulin subcutaneous) and albumin-based products.
Development of the Covington site is part of Shire's manufacturing network review, which completed last year and was partly aimed at streamlining in the wake of the Baxalta acquisition.
Following that deal, Shire found itself with extra biologics capacity, leading to its decision to sell two sites (with plans to dives three more in biologics).
"This allows us to focus our investments on the remaining assets including continued investment to support our growing immunology business and best utilize our fixed infrastructure as a competitive advantage," said Matt Walker, company head of technical operations, on a third quarter earnings call.
Shire currently has seven biologics production sites and eight plasma manufacturing facilities.
While shrinking down its biologics production footprint on one hand, Shire has also sought to boost its plasma capacity. Covington is a key part of that, as is expanding the number of plasma collection sites.
"We will also continue to open new plasma collection centers, ramping our current planned opening rate from mid-single digit centers to double digits annually while optimizing the recovery from our existing centers to support the growing demands of our immunology products," Walker said.
- Shire plc Press release
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