High quality human immunoglobulin G purified from Cohn fractions by liquid chromatography

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, QSepharose 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 o 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: IgG 1 = 58.4%, IgG 2 = 34.8%, IgG 3 = 4.5% and IgG 4 = 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 CH 50 /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.

Purification of intravenous immunoglobulin G from human plasma – aspects of yield and virus safety

“…A purification processes containing a SEC as polishing step has been described [54]. Tanaka et al (2000) reported a purification process for IVIG starting with the reconstitution of Fraction II+III, followed by two chromatography steps on Q-Sepharose and CM-Sepharose and finally a SEC on Sephacryl S-300 [55]. A yield of 4.3 g/L plasma was disclosed.…”

Adsorption of human serum proteins onto TREN-agarose: Purification of human IgG by negative chromatography

“…Therefore, there is a high demand for high purity IgG, free from other serum proteins. Processes for the purification of human IgG typically involve precipitation with ethanol followed by chromatographic techniques (such as ion exchange chromatography, gel permeation chromatography, or affinity chromatography) [2,3].…”

A new liquid, intravenous immunoglobulin product (IGIV 10%) highly purified by a state‐of‐the‐art process

“…Tanaka et al . [14] used Cohn fraction (I+)II+III as starting material and Q-Sepharose and CM-Sepharose (GE Healthcare, Uppsala, Sweden) as ion-exchange chromatographic steps for producing a highly purified immunoglobulin preparation. Baxter's Gammagard SD (Baxter International Inc, Deerfield, IL, USA) is another good example of a product manufactured in a similar manner.…”