Process for preparing an activated factor VII concentrate having a high purity
The invention relates to a process for preparing an activated factor VII concentrate of high purity. This process comprises the use of a plasma free of cryoprecipitate, preferably of human origin, as well as at least one purification step using at least one ion-exchange resin chromatography as well...
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Zusammenfassung: | The invention relates to a process for preparing an activated factor VII concentrate of high purity. This process comprises the use of a plasma free of cryoprecipitate, preferably of human origin, as well as at least one purification step using at least one ion-exchange resin chromatography as well as one factor VII activation step, characterised in that the direct activation of factor VII is first carried out in the crude plasma supernatant free of cryoprecipitate, without providing exogenous proteins. By virtue of the invention, the activated factor VII of high purity is essentially free of vitamin K-dependent factors and of VIIIC and VIIICAg factors and has a factor VIIa/factor VII ratio greater than 5 with an actived factor VII specific activity greater than 200 IU/mg of protein. |
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