Comparability Assessments of Process Changes Made during Development of Anti-Idiotype Vaccine

• 作者: Adolfo Castillo Ana Maria Vazquez Blanca Pacheco Dasha Fuentes Julio Felipe Santo Tomás Kathya de la Luz-Hernández Orlando Morales Raquel Montesinos Yadira Aguilar Yamilé Rabasa
• 来源期刊: 疫苗(英文)
• 学科: 医学
• 关键词: Comparability Studies MONOCLONAL ANTIBODY Cancer VACCINE Mass SPECTROMETRY
• 年，卷（期）: ymyw_2014,（1）
• 页码范围: 24-32
• 页数: 9页
• 分类号: R73

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.