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Methods for the industrial scale production of therapeutic preparations of complement factor H from human plasma
专利权人:
CSL BEHRING GMBH
发明人:
LIEBING, Uwe,KARGES, Hermann
申请号:
ES08716651
公开号:
ES2595059T3
申请日:
2008.03.20
申请国别(地区):
ES
年份:
2016
代理人:
摘要:
A method for purification of complement Factor H in a solution comprising the steps of: a) providing a fraction comprising complement Factor H by large-scale fractional precipitation of human serum or plasma with ethanol, whereby said process of Large-scale fractional precipitation produces at least one additional commercially available pharmaceutical protein; b) further purifying Complement Factor H by at least one purification method selected from the following group: I. Heparin II Affinity Chromatography. Hydrophobic Interaction Chromatography (HIC) III. Anion exchange chromatography (AEC) IV. Cation Exchange Chromatography (CEC) V. Hydroxyapatite Chromatography (HAC) VI. Immunoaffinity chromatography c) treating the complement Factor H-containing fraction at least once before, during or after step b) of said purification process with a virus / pathogen inactivation and / or elimination method; where the purification of complement Factor H comprises the following process steps: I. an initial anion exchange chromatography II. followed by hydrophobic interaction chromatography III. followed by pasteurization IV. followed by heparin V affinity chromatography followed by nanofiltration.Un método para la purificación de Factor H del complemento en una solución que comprende los pasos de: a) proporcionar una fracción que comprende Factor H del complemento mediante la precipitación fraccionada a gran escala de suero o plasma humano con etanol, donde mediante dicho proceso de precipitación fraccionada a gran escala se produce al menos una proteína farmacéutica adicional que se puede obtener comercialmente; b) purificar adicionalmente el Factor H del complemento mediante al menos un método de purificación seleccionado del grupo siguiente: I. Cromatografía de afinidad de heparina II. Cromatografía de interacción hidrófoba (HIC) III. Cromatografía de intercambio aniónico (AEC) IV. Cromatografía de intercambio catiónico (CEC) V. Cromatografía de hidroxiapatita (HAC) VI. Crom
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