Cinryze (C1 esterase inhibitor [human]) is an injectable medicine derived from human plasma used to help prevent swelling and/or painful attacks in patients with the rare genetic disease Hereditary Angioedema (HAE).
Manufacture of the drugs requires a series of precipitation, filtration and chromatography steps.
Shire will continue to employ Dutch contract manufacturing organisation (CMO) Sanquin Blood Supply to make Cinryze, and said the technology transfer adds a second production source for the drug to ensure supply meets patient demand.
“Internalising the production of Cinryze adds a second source for the product and thereby reduces any risks to supply for the HAE patients who count on Cinryze to prevent attacks,” a spokesperson told us.
Production at the Vienna facility will begin in the first quarter of 2018.
Last month, Shire requested the US Food and Drug Administration’s (FDA) permission to transfer technology to make Gammagard Liquid – a plasma-derived antibody product used to treat primary humoral immunodeficiency (PI) – at its facility in Covington, Georgia.