Xu Jian, Shao Zhihui, Han Xiaoxiong, Huang Yingfeng, Zou Xun, Shen Yaling
State Key Laboratory of Bioreactor Engineering, Shanghai Collaborative Innovation Center for Biomanufacturing Technology, East China University of Science and Technology, 130 Mei Long Road, Shanghai, 200237, China.
CAS Key Laboratory of Synthetic Biology, CAS Center for Excellence in Molecular Plant Sciences, Institute of Plant Physiology and Ecology, Chinese Academy of Sciences, Shanghai, China.
Bioresour Bioprocess. 2021 Mar 29;8(1):24. doi: 10.1186/s40643-021-00378-2.
The development of biosimilar products or follow-on biologics has been flourishing in recent years because of their lower price than the originators. In this study, a multivariate data analysis method based on JMP software was proposed to assess the glycosylation pattern similarity of antibody candidates from different conditions in optimization experiments with a reference. A specific distance was generated by this method and indicated the glycoform similarity between the biosimilar and the reference. This method can be applied to analyze the similarity of other physicochemical and functional characteristics between follow-on biologics and originators. Then, the design of experimental methods can be realized to optimize the conditions of cell culture to attain similar antibody candidates. A higher concentration of GlcNAc added to the basal media made the glycan of the antibody more similar to the glycan of the reference in this study.
近年来，生物类似药或后续生物制品的开发蓬勃发展，因为它们的价格低于原创药。在本研究中，提出了一种基于JMP软件的多变量数据分析方法，以评估优化实验中不同条件下候选抗体与参考抗体的糖基化模式相似性。该方法生成了一个特定的距离，表明生物类似药与参考抗体之间的糖型相似性。此方法可用于分析后续生物制品与原创药之间其他物理化学和功能特性的相似性。然后，可以实现实验方法的设计，以优化细胞培养条件，获得相似的候选抗体。在本研究中，向基础培养基中添加更高浓度的N-乙酰葡糖胺可使抗体的聚糖更类似于参考抗体的聚糖。
