Method of producing intravenously injectable gamma globulin

A - Human Necessities – 61 – K

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A61K 39/395 (2006.01) A61K 35/14 (2006.01) C07K 16/06 (2006.01) A61K 38/00 (2006.01)

Patent

CA 1100872

Abstract of the Disclosure The invention relates to a process for the preparation of a gamma globulin fraction suitable for intravenous administra- tion and being substantially free of anti-complementary activity. The process involves extracting a paste or powder of Fraction II or II + III plasma protein or of a placental extraction contain- ing the Fraction with pyrogen-free water at a pH of from 4.9 to 6; separating the extract thus obtained from solid material and treating the extract with polyethylene glycol in an amount of about 4% weight/volume; separating the glycol-treated extract from solid material thus precipitated and subsequently treating with ethanol in an amount of from 4 to 12% weight/volume at temperatures of from -6 to 10°C; separating solid material from the ethanol-treated extract thus obtained to yield a further extract; and isolating the gamma globulin fraction from the further extract at temperatures of from -6 to 20°C and at a pH of from 7 to 8.2 by means of the addition of either polyethylene glycol in an amount of up to 12% weight/volume or of ethanol in an amount of up to 30% volume/volume, the gamma globulin fraction being substantially free of anti-complementary activity.

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