PROCESS FOR PRODUCING IMMUNOGLOBULIN FOR INTRAVENOUS ADMINISTRATION AND OTHER IMMUNOGLOBULIN PRODUCT

摘要

PPROBLEM TO BE SOLVED: To provide a process for purifying immunoglobulin G from a crude immunoglobulin-containing plasma protein fraction. PSOLUTION: In the process, anion exchange chromatography and cation exchange chromatography are preferably connected in series and an acetate buffer solution having a pH of about 5.0-6.0 and a molarity of about 5-25 mM is used throughout the purification process. The immunoglobulin product obtained by the process has a purity of higher than 98% and a content of IgG monomers and dimers of more than 98.5% and a content of IgA of less than 4 mg/l, and contains less than 0.5% of polymers and aggregates. The product does not contains a detergent, PEG or albumin as a stabilizer. The product is stable, virus-safe, liquid and ready for instant intravenous administration. PCOPYRIGHT: (C)2011,JPO&INPIT