Process for the production of a reversibly inactive...

C - Chemistry – Metallurgy – 12 – N

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C12N 9/68 (2006.01) A61K 38/48 (2006.01) A61K 38/00 (2006.01) A61K 47/02 (2006.01) A61K 47/12 (2006.01) A61K 47/18 (2006.01) A61K 47/26 (2006.01)

Patent

CA 2389487

Disclosed is both a process for producing a reversibly inactive acidified plasmin by activating plasminogen and a process for producing a purified plasminogen. The produced plasmin is isolated and stored with a low pH- buffering capacity agent to provide a substantially stable formulation. The purified plasminogen is typically purified from a fraction obtained in the separation of immunoglobulin from Fraction II + III chromatographic process and eluded at a low pH. The reversibly inactive acidified plasmin may be used in the administration of a thrombolytic therapy.

L'invention concerne un procédé de production d'une plasmine acidifiée inactivée de manière réversible par activation du plasminogène ainsi qu'un procédé de production d'un plasminogène purifié. La plasmine est isolée et stockée avec un agent à faible capacité de tamponnage du pH afin d'obtenir une formulation sensiblement stable. Ce plasminogène purifié est généralement purifié d'une fraction obtenue dans le séparation de l'immunoglobuline de la fraction II + III par un procédé chromatographique et il subit une élution à un faible pH. La plasmine acidifiée inactivée de manière réversible peut être utilisée dans l'administration d'une thérapie thrombolytique.

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