Date: 2017-12-27
Type of information: Validation of a production plant
Compound: plasma manufacturing facility in Covington
Company: Shire (UK - USA)
Therapeutic area: Rare diseases - Genetic diseases - Hematological diseases
Type agreement: validation of a production plant
Action mechanism:
Disease:
Details:
- • On December 27, 2017, Shire announced that it has filed its first submission to the FDA for the company’s new plasma manufacturing facility in Covington, Georgia. The facility is expected to add approximately 30% capacity to the company’s internal network once fully operational. Commercial production is 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 (PI). The company expects to make a second submission to the FDA in 2018 for its albumin therapy, which is primarily used as plasma-volume replacement therapy in immune disorders, trauma and other critical conditions.
- The Covington, Georgia site currently employs approximately 900 full-time colleagues and contract employees. The site plans to ramp up hiring in 2018 to fill roles in manufacturing, quality, engineering, maintenance, utilities, warehouse and a variety of support and facility roles.
- Shire also expects to continue expansion of its plasma collection network in Georgia and throughout the United States through its subsidiary, BioLife Plasma Services. BioLife collects the human plasma that will be processed into the drugs manufactured at Shire’s new Covington, Georgia facility.
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Is general: Yes
