Comparative study on the quality of human immunoglobulin for intravenous injection prepared by different processes

Objective To compare and analyze the quality of human immunoglobulin for intravenous injection (IVIG) (pH4) prepared by low-temperature ethanol protein separation and that of IVIG (10%) prepared by two-step anion exchange chromatography. Methods The IgA content, molecular size distribution, anti-HBs titer, protein spatial structure, Fc fragment activity, antibody spectrum and IgG subtype distribution of IVIGs prepared by 2 different processes were detected and compared. Results The IgA content of IVIG from two-step anion exchange chromatography (5.30 μg/ml) was significantly lower than that of IVIG from low-temperature ethanol separation (281.95 μg/ml), and there was no significant difference in molecular size distribution, anti-HBs titer, protein spatial structure, Fc fragment activity, antibody spectrum and IgG subtype distribution indexes. Conclusion IVIG (10%) prepared by two-step anion exchange chromatography has better safety. Key words: Human immunoglobulin for intravenous injection; Comparative study; Immunoglobulin A