C - Chemistry – Metallurgy – 12 – N
Patent
C - Chemistry, Metallurgy
12
N
C12N 9/74 (2006.01)
Patent
CA 2609520
The invention relates to thrombin compositions with reduced levels of high molecular weight impurities. In particular, the levels of factor Va, prions and/or viral agents are greatly reduced. This invention also relates generally to methods for the preparation of thrombin having a high degree of purity and high specific activity. More specifically, the invention encompasses steps to exclude high molecular weight impurities from thrombin preparations by size exclusion filtration. In additional embodiments, the preparation of thrombin additionally includes an ion exchange filtration step. The methods of the invention are particularly suited for large scale purification of thrombin. This invention also relates generally to stabilized formulations containing thrombin compositions. More specifically, the present invention relates to stabilized, liquid formulations containing thrombin having a high degree of purity and high specific activity and methods of making and using such formulations.
Compositions de thrombine à niveaux réduit d'impuretés de haut poids moléculaire. On réduit largement en particulier les niveaux de facteur Va, les prions et/ou les agents viraux. Globalement aussi, procédés d'élaboration de thrombine à haut degré de pureté et activité spécifique élevée. Plus précisément, étapes visant à exclure les impuretés mentionnées des préparations de thrombine par filtration d'exclusion de taille. Sous d'autres variantes, l'élaboration de thrombine comprend aussi une étape de filtration échangeuse d'ions. Les procédés décrits sont particulièrement appropriés à la purification de thrombine à grande échelle. Plus précisément, formulations liquides stabilisées contenant de la thrombine à haut degré de pureté et activité spécifique élevée, et procédés d'élaboration et d'utilisation correspondantes.
Chesmore Gerald
Irwin J. Foster
Knoll Bradley H.
Pawlak Dan
Terrab Abdel Hak
King Pharmaceuticals Research & Development Inc.
Smart & Biggar
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