抗独特型疫苗研制过程中工艺变化的可比性评价

K. D. L. Luz-Hernández, Y. Rabasa, R. Montesinos, D. Fuentes, Julio Felipe Santo Tomás, O. Morales, Y. Aguilar, B. Pacheco, A. Castillo, A. Vázquez
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引用次数: 1

摘要

Racotumomab单克隆抗体是一种小鼠抗独特型抗体。该单克隆抗体模拟n-糖酰gm3神经节苷脂,已在乳腺癌、黑色素瘤和非小细胞肺癌患者的I/II期临床试验中作为抗独特型癌症疫苗进行了测试。早期的生产过程是在小鼠腹水中进行的。该工艺在中试阶段转移到基于生物反应器的方法,随后扩大了发酵的规模。在这项工作中,我们提出了两种不同生产规模生产的racotumomab MAb的综合分子表征,以确定生产工艺对疫苗性能的影响。我们观察到两种尺度生产的racotumomab在糖基化模式和电荷异质性上的差异。有趣的是,这些修饰对鸡的生物活性没有显著影响。因此,糖基化、电荷异质性和氧化等一级结构的变化不会影响疫苗的生物活性。
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Comparability Assessments of Process Changes Made during Development of Anti-Idiotype Vaccine
Racotumomab monoclonal antibody is a murine anti-idiotypic antibody. This monoclonal antibody mimics N-glycolyl-GM3 gangliosides has been tested in several clinical trials Phase I/II for breast, melanoma and non-small cell lung cancer patients as an anti-idiotypic cancer vaccine. The early production process was performed in vivo from mice ascites fluid. This process was transferred to bioreactor-based method at pilot scale followed to the scale-up of the fermentation. In this work we present a comprehensive molecular characterization of racotumomab MAb produced by the two different production scales in order to determine the impact of the manufacturing process in vaccine performance. We observed differences in glycosylation pattern and charge heterogeneity between racotumomab produced in both scales. Interestingly, these modifications had no significant impact on biological activity elicited in chickens. So, changes in primary structure like glycosylation, charge heterogeneity and oxidation did not affect biological activity of the vaccine.
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