METHOD OF PRODUCING IMMUNOGLOBULIN PREPARATION FOR INTRAVENOUS
A method of producing immunoglobulin preparations for intravenous injection which starts with an immunoblobulin-containing fraction and comprises the treatment steps of: (a) treating said fraction with 4-l0 weight/volume percent of polyethylene glycol having a molecular weight of l,000-l0,000 under...
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Zusammenfassung: | A method of producing immunoglobulin preparations for intravenous injection which starts with an immunoblobulin-containing fraction and comprises the treatment steps of: (a) treating said fraction with 4-l0 weight/volume percent of polyethylene glycol having a molecular weight of l,000-l0,000 under conditions of pH 4-6, ion strength 0.000l-0.l M and temperature 0-4 DEG C and recovering the supernatant, (b) treating the supernatant obtained in step (a) with l0-l5 weight/volume percent of polyethylene glycol having a molecular weight. of l,000-l0,000 under conditions of pH 6-9, ion strength 0.000l-0.l M and temperature 0-4 DEG C and recovering the resulting precipitate, and (c) heat-treating, in any desired step, said immunoglobulin in the presence of a stabilizer under conditions sufficient to inactivate contaminant viruses. The preparations obtained according to the invention retain immunoglobulins without substantial inactivation thereof, and are substantially free of such contaminants as anti-human blood group substance antibodies. With contaminant viruses inactivated as a result of the heat treatment, said preparations have good solubility and are sufficiently low in anticomplement activity. |
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