A procedure for Preparation of intravenous human immunoglobulin G and obtained intravenous human immunoglobulin g

摘要

Includes a first step of adding a Solvent selected from water, a solution of amino acid and saline solution, with added Stabilizer selected from a polyol, an amino acid and carbohydrate; a second step of warming to between 43 and 68u00b0C for between 7 and 12 ho Ras; a Third step of ultrafiltration with a preconcentration step.A stage of diafiltration and a concentration step; a Fourth step of adjustment of conditions that includes stage of adding sucrose and Glycine Solid Water added, a Stage, a stage of adjustment of the concentration of added Protein and a stage of Pepsin; a Fifth Step F Iltraciu00f3n; a Sixth step of disaggregation with agitation at Constant SpeedConstant temperature of between 33 and 4 1 degrees centigrade and space between 16 and 36 hours; a Seventh Step ultrafiltration Stage comprising a dilution with a solution of Glycine and one Stage ultrafiltration and diafiltration using washing Solution Quality acidulous Water injection Eighth step, a final formulation comprising a step of adding a solution of Glycine and MilgrainThe Protein concentration of the added Glycine, a sound Stage, a stage of a phase of Sorbitol addition and PH adjustment step; a Ninth and tenth final Filtration; a step of packaging of the product.