| 摘要 |
The invention relates to the sphere of manufacturing immunoglobulin products for intravenous administration. Disclosed is a method for preparing an enriched IgG composition from cryo-poor plasma, the method comprising the steps of precipitating a cryo-poor plasmid fraction, in a first precipitation step, with alcohol to obtain a first precipitate and a first supernatant comprising IgG; precipitating IgG from the first supernatant, in a second precipitation step, with alcohol to form a second precipitate comprising IgG; re-suspending the second precipitate in an extraction buffer to form a suspension; precipitating IgG from said suspension with alcohol to form a third precipitate comprising IgG; re-suspending the third precipitate in an aqueous solution to form a suspension having a soluble fraction comprising IgG and an unsoluble fraction; and separating the soluble fraction from said suspension, thereby forming an enriched IgG composition, wherein at least one of the first precipitation step, second precipitation step, or third precipitation step comprises spray addition of the alcohol. The invention may be used for improving the methods for manufacturing immunoglobulin products for intravenous administration. |
