PRODUCT LITERATURE
L-Proline reduces IgG dimer content and enhances the stability of intravenous immunoglobulin (IVIG) solutions
Liquid intravenous immunoglobulin (IVIG) products offer improved convenience in preparation but often lack sufficient stability to allow room temperature storage. Furthermore, clinical tolerability may be affected due to formation of idiotype/anti-idiotype IgG dimers and/or aggregates. Here we report on the development of a 10% IVIG formulation with optimized stability achieved by the use of L-proline. The stability of concentrated liquid IVIG was strongly pH dependent. Aggregate formation, yellowish
discoloration of the solution and loss of anti-hepatitis B surface antigen (HBs) antibody activity was minimal at intermediate pH (pH 4.8–5.3)
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