Abstract
New requirements regarding the exclusion of virus transmissions have led to new production methods of commercial IgG preparations. Nevertheless, the protein and antibody composition necessary for safe and efficacious preparations must be guaranteed. Minimal requirements have been defined by European Pharmakopeia and DAB 10 and are usually met by commercial IgG preparations. However, significant differences, depending on production methods and origin of donors, have been observed regarding the content of stabilizers, polymers and aggregates, IgA, IgG subclasses and also antibody titers and activities. Most of these quality criteria can be monitored by well standardized electrophoretic, immunological or chromatographic methods. A safe and universally applicable IgG preparation should be characterized by a low content of polymers and IgA, a physiological IgG subclass distribution and high antibody activities against relevant infectious agents. These requirements are more easily met by preparations not chemically or enzymatically modified.
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