Shire secures Cinryze supply with tech transfer to Austria

By Flora Southey

- Last updated on GMT

GettyImages/thumb
GettyImages/thumb
The US FDA has approved Shire’s request to make rare genetic disease treatment Cinryze at its manufacturing facility in Vienna.

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.

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