BRUCKSCHWAIGER, LEOPOLD,SVATOS, SONJA,NÜRNBERGER, JULIA,TESCHNER, DR. WOLFGANG,BUTTERWECK, HARALD ARNO,SCHWARZ, DR. HANS-PETER,GUNDINGER, THOMAS,KOELBL, BERNHARD,GRAUSENBURGER, REINHARD,PLJEVLJAKOVIC,
申请号：
ES12190138
公开号：
ES2536093T3
申请日:
2010.05.27
申请国别(地区):
ES
年份:
2015
代理人:
摘要：
A process comprising the steps of: (a) precipitating a plasma fraction devoid of cryoprecipitate, in a first stage of precipitation, with alcohol between about 6% and about 10% at a pH between about 6.7 and about 7.3 to obtain an IgG-enriched supernatant； (b) precipitate the IgG of the supernatant with alcohol between about 20% and about 30% at a lower temperature and at a pH between about 6.7 and about 7.3 to form a first precipitate； (c) resuspend the first precipitate formed in step (b) to form a suspension； (d) treating the suspension formed in step (c) with a detergent, (e) precipitating the IgG of the suspension with alcohol between about 20% and about 30% at a pH between about 6.7 and about 7 , 3 to form a second precipitate； (f) resuspend the second precipitate formed in step (e) to form a suspension； (g) treating the suspension formed in step (f) with a solvent and / or detergent； and (h) perform at least one fractionation by ion exchange chromatography thus preparing a concentrated IgG composition, in which the process further comprises treating the suspension formed in step (c) with finely divided silicon dioxide (SiO2) and filtering the solution before step (d).Un procedimiento que comprende las etapas de: (a) precipitar una fracción de plasma desprovisto de crioprecipitado, en una primera etapa de precipitación, con alcohol entre aproximadamente un 6 % y aproximadamente un 10 % a un pH de entre aproximadamente 6,7 y aproximadamente 7,3 para obtener un sobrenadante enriquecido en IgG； (b) precipitar la IgG del sobrenadante con alcohol entre aproximadamente un 20 % y aproximadamente un 30 % a una temperatura inferior y a un pH de entre aproximadamente 6,7 y aproximadamente 7,3 para formar un primer precipitado； (c) resuspender el primer precipitado formado en la etapa (b) para formar una suspensión； (d) tratar la suspensión formada en la etapa (c) con un detergente, (e) precipitar la IgG de la suspensión con alcohol entre aproximadamente un 20 % y aproxim
