Column Ion Exchange Chromatographic Production of Human Immune Serum Globulin for Intravenous Use

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Abstract
Column ion exchange chromatographic processes were developed for the production of immune serum globulin (ISG) for intravenous use. Sequential chromatography on two cross‐linked agarose gel anion exchangers yielded the same immunoelectrophoretic pure ISG as a single column DEAE‐Sephadex procedure with the advantage of repeated ‘in column’ cycling. ISG with a low content of aggregated IgG and low anticomplementary activity was prepared from plasma with 53–69% efficiency. The ISG prepared by these processes was characterized with respect to the content of IgA, prekallikrein activator (PKA), plasminogen, fragmentation, and heavy chain subclass distribution.