RESUMEN
In order to obtain intravenous immunoglobulin G (iv IgG) of high quality from F-I+II+III or F-II+III pastes prepared by the Cohn method, we developed a chromatography process using ion exchange gels, Q-Sepharose FF and CM-Sepharose FF, and Sephacryl S-300 gel filtration. Viral inactivation was performed by incubating the preparation with pepsin at pH 4.0 at 35oC for 18 h. The characteristics of 28 batches produced by us were: yield 4.3 + or - 0.2 g/l plasma, i.e., a recovery of 39.1 + or - 1.8 percent; IgG subclasses distribution: IgG1 = 58.4 percent, IgG2 = 34.8 percent, IgG3 = 4.5 percent and IgG4 = 2.3 percent; IgG size distribution was 98.4 percent monomers, 1.2 percent dimers and 0.4 percent polymers and protein aggregates; anticomplement activity was less than 0.5 CH50/mg IgG, and prekallikrein activator activity (PKA) was less than 5 IU/ml. These characteristics satisfied the requirements of the European Pharmacopoea edition, and the regulations of the Brazilian Health Ministry (M.S. Portaria No. 2, 30/10/1998)