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Physicochemical and biological characterization of 1E10 Anti-Idiotype vaccine

机译：1E10抗独特型疫苗的理化和生物学特性

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Background 1E10 monoclonal antibody is a murine anti-idiotypic antibody that mimics N-glycolyl-GM3 gangliosides. This antibody has been tested as an anti-idiotypic cancer vaccine, adjuvated in Al(OH)3, in several clinical trials for melanoma, breast, and lung cancer. During early clinical development this mAb was obtained in vivo from mice ascites fluid. Currently, the production process of 1E10 is being transferred from the in vivo to a bioreactor-based method. Results Here, we present a comprehensive molecular and immunological characterization of 1E10 produced by the two different production processes in order to determine the impact of the manufacturing process in vaccine performance. We observed differences in glycosylation pattern, charge heterogeneity and structural stability between in vivo -produced 1E10 and bioreactor-obtained 1E10. Interestingly, these modifications had no significant impact on the immune responses elicited in two different animal models. Conclusions Changes in 1E10 primary structure like glycosylation; asparagine deamidation and oxidation affected 1E10 structural stability but did not affect the immune response elicited in mice and chickens when compared to 1E10 produced in mice.
机译：背景技术1E10单克隆抗体是模仿N-糖基-GM3神经节苷脂的鼠类抗独特型抗体。在针对黑素瘤，乳腺癌和肺癌的多项临床试验中，已将该抗体作为抗独特型癌症疫苗进行了测试，并在Al（OH） 3 中进行了修饰。在早期临床开发过程中，该mAb是从小鼠腹水液中体内获得的。当前，1E10的生产过程正在从体内转移到基于生物反应器的方法上。结果在这里，我们介绍了由两种不同生产工艺生产的1E10的分子和免疫学特性，以确定生产工艺对疫苗性能的影响。我们观察到在体内产生的1E10和生物反应器获得的1E10之间糖基化模式，电荷异质性和结构稳定性的差异。有趣的是，这些修饰对在两种不同动物模型中引起的免疫反应没有显着影响。结论1E10一级结构的改变如糖基化;与小鼠产生的1E10相比，天冬酰胺的脱酰胺作用和氧化作用影响1E10的结构稳定性，但不影响小鼠和鸡的免疫应答。

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