Process for the preparation in pure form of the protease...

C - Chemistry – Metallurgy – 12 – N

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C12N 9/50 (2006.01) A61K 38/43 (2006.01) C12N 9/64 (2006.01) C12Q 1/37 (2006.01) C12Q 1/56 (2006.01) G01N 33/573 (2006.01) G01N 33/86 (2006.01) A61K 38/00 (2006.01)

Patent

CA 2315306

A process for the preparation in pure form of the protease activating blood clotting factor VII and/or its proenzyme is described in which these are obtained from biological fluids or those obtained in the case of preparation by genetic engineering a) by anion- or cation-exchange chromatography at a pH below the isoelectric point of the protein to be isolated or b) by a combination of anion- or cation-exchange chromatography with affinity chromatography and/or fractional precipitation at pHs of between 2.5 and 9.0, preferably between 2.5 and 7.2, the affinity chromatography being carried out using - calcium phosphate/hydroxyapatite - a hydrophobic matrix, - a chelate matrix, - a matrix which is coated with an immobilized monoclonal or polyclonal antibody directed against the protein to be isolated, or its F(ab) or F(ab)2 fragments. A pharmaceutical preparation and a reagent are moreover described which contain the said protease and its proenzyme.

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