文章基本信息

标题：Comparability Assessments of Process Changes Made during Development of Anti-Idiotype Vaccine
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作者：Kathya de la Luz-Hernández ; Yamilé Rabasa ; Raquel Montesinos 等
期刊名称：World Journal of Vaccines
印刷版ISSN：2160-5815
电子版ISSN：2160-5823
出版年度：2014
卷号：04
期号：01
页码：24-32
DOI：10.4236/wjv.2014.41005
语种：English
出版社：Scientific Research Publishing
摘要：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.
关键词：Comparability Studies; Monoclonal Antibody; Cancer Vaccine; Mass Spectrometry