Abstract
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 35 degrees C for 18 h. The characteristics of 28 batches produced by us were: yield 4.3 +/- 0.2 g/l plasma, i.e., a recovery of 39.1 +/- 1.8%; IgG subclasses distribution: IgG1 = 58.4%, IgG2 = 34.8%, IgG3 = 4.5% and IgG4 = 2. 3%; IgG size distribution was 98.4% monomers, 1.2% dimers and 0.4% 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).
Highlights
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, QSepharose FF and CM-Sepharose FF, and Sephacryl S-300 gel filtration
Albumin is produced by the method of Cohn [1] at several human plasma fractionation centers in South America
In order to obtain IgG of excellent quality from the FI+II+III or F-II+III pastes produced by the method of Cohn, we developed a process in which these precipitates can be submitted to chromatography using three kinds of gels: two ion exchange gels (Q-Sepharose FF and CM-Sepharose FF) and gel filtration (Sephacryl S-300 HR)
Summary
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, QSepharose FF and CM-Sepharose FF, and Sephacryl S-300 gel filtration. In order to obtain IgG of excellent quality from the FI+II+III or F-II+III pastes produced by the method of Cohn, we developed a process in which these precipitates can be submitted to chromatography using three kinds of gels: two ion exchange gels (Q-Sepharose FF and CM-Sepharose FF) and gel filtration (Sephacryl S-300 HR).
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