Patent ID: 6893639

Claim:
A method for producing a high yield of purified immune globulins from blood plasma, comprising: providing a plasma source containing immune globulins; suspending the immune globulins in an ethanol solution at a volume equivalent to two times that of the plasma source at a temperature in a range of about −4° C. to −6° C.; adjusting the pH of the suspension to about 5.7 to 5.8; incubating the suspension for at least two hours; adding a volume of a solution of about 2.4M glycine in about 7% ethanol and purified water (volume/volume) equivalent to the volume of the plasma source to the suspension; adjusting the pH of the suspension to about 5.2 to 5.4; extracting the immune globulins from the suspension in a liquid phase to provide an extract containing immune globulins; concentrating the extract containing immune globulins by ultrafiltration of the extract containing immune globulins to provide an immune globulin solution of approximately 1.0 gram/deciliter immune globulins content; performing solvent-exchange on the immune globulin solution with a sodium phosphate solution to provide an extract solution containing immune globulins; removing any impurities from the extract solution containing immune globulins using an anion exchange chromatography column to provide a purified extract solution containing immune globulins; concentrating the purified extract solution containing immune globulins deriving from an effluent of the anion exchange chromatography column by ultrafiltration to provide a concentrated purified extract solution containing immune globulins; inactivating viruses present in the concentrated purified extract solution containing immune globulins; passing the concentrated purified extract solution containing immune globulins through a column containing C-18 resin for removal by adsorption of any residue in the concentrated purified extract solution containing immune globulins from the step of inactivating viruses, wherein the ratio of immune globulins load volume to resin volume is approximately eight parts load volume to one part C-18 resin; and formulating the concentrated purified extract solution containing immune globulins for final use.