Pasteurization of immunoglobulin solutions

Details Pasteurization of immunoglobulin solutions Pasteurization of immunoglobulin solutions

A - Human Necessities

61

K

A61K 39/395 (2006.01) A61L 2/00 (2006.01) A61L 2/04 (2006.01)

Patent

CA 2261291

A process for the pasteurization of an immunoglobulin solution, particularly an IgG solution, comprises heating the solution at a temperature of 50 ~C to 70 ~C for a period of from 1 to 20 hours, at a pH of 4.0 to 6.0 in the presence of 20 to 40 % w/v sorbitol or 25 to 45 % w/v sucrose, and wherein the protein concentration of the solution is approximately 3 % w/v or less.

Cette invention concerne un procédé de pasteurisation d'une solution d'immunoglobulines, et notamment une solution de gammaglobulines, qui consiste à chauffer la solution à une température comprise entre 50 ·C et 70 ·C pendant un laps de temps compris entre 1 et 20 heures, à un pH compris entre 4,0 et 6,0, et en présence de 20 à 40 % en poids de sorbitol ou de 25 à 45 % en poids de saccharose, la concentration en protéines de la solution étant approximativement inférieure ou égale à 3 % en poids.

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