Pincus J H, Mortelmans K, Tanaka W, Stephan W, Lissner R
Arzneimittelforschung. 1981;31(11):1924-8.
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.
在生产静脉内可耐受的IgG免疫球蛋白制剂Intraglobin过程中，科恩II组分用β-丙内酯处理。由此，IgG分子发生化学修饰，从而防止二级聚集体增加，而二级聚集体增加可能导致接受该IgG制剂治疗的患者出现不良反应。此处描述的安全性测试既未显示最终产品中存在未水解的诱变β-丙内酯的证据，也未显示β-丙内酯与蛋白质分子反应产生新抗原决定簇的证据。
