PRODUCTION OF IMMUNOGLOBULIN G

PURPOSE:To obtain in high recovery an IgG pharmaceutical for intravenous injection with low anticomplementary activity, through such processes that flocculates are removed from an aqueous IgG solution followed by filtration in the presence of a surface-active stabilizer through a polyolefin porous membrane to effect prevention of IgG flocculation. CONSTITUTION:Flocculates are removed from an aqueous solution of immunoglobulin G fractionated from human plasma to such an extent as not to be detectable by gel permeation analysis. The resulting solution is then filtered, in the presence of a surface-active stabilizer such as serum albumin, corn fraction V, polyvinylpyrrolidone or polyethylene glycol, through a porous polyolefin membrane 0.015-0.17 (esp. 0.02-0.06)mum in the pore size determined by the uniform particle filtration technique. For removing the flocculates, an adsorption technique using tricalcium phosphate is preferable. The IgG concentration in the IgG stock solution in performing the membrane filtration is pref. 1-10wt.%, and 0.1-1 pt.wt. of the stabilizer is used based on 1 pt.wt. of IgG.