On the mutagenicity and immunogenicity of a beta-propiolactone-treated therapeutic IgG-preparation.
During the production of Intraglobin, an i.v. tolerable IgG-immunoglobulin preparation, fraction Cohn II is treated with beta-propiolactone. Thereby the IgG-molecules are chemically modified thus preventing an increase in secondary aggregates which could give rise to adverse reactions in the patients treated with the IgG-preparation. The safety tests described here neither showed any evidence for the presence of unhydrolysed mutagenic-beta-propiolactone in the final product nor that neoantigenic determinants had been created by the reaction of beta-propiolactone with the protein molecules.
D000818:Animals; D000917:Antibody Formation / Q000187:drug effects; D005260:Female; D006168:Guinea Pigs; D007074:Immunoglobulin G / Q000031:analogs & derivatives* / Q000276:immunology / Q000633:toxicity; D016756:Immunoglobulins, Intravenous; D009153:Mutagens; D011420:Propiolactone; D012756:Sheep / Q000276:immunology; D012882:Skin Tests; D005719:gamma-Globulins / Q000494:pharmacology
D007074:Immunoglobulin G; D016756:Immunoglobulins, Intravenous; D009153:Mutagens; D005719:gamma-Globulins; D011420:Propiolactone