Challenges Of Glycosylation Analysis And Control: An Integrated Approach To Producing Optimal And Consistent Therapeutic Drugs
Authors: Peiqing Zhang, Susanto Woen, Tianhua Wang, Brian Liau, Sophie Zhao, Chen Chen, Yuansheng Yang, Zhiwei Song, Mark R. Wormald, Chuanfei Yu, Pauline M. Rudd
Abstract:
The safety and effectiveness of therapeutic proteins are greatly influenced by glycosylation, a process that adds sugar molecules to these proteins. Numerous factors contribute to the glycosylation of biotherapeutics, including the expression systems, cell culture processes, and purification strategies used. To address various aspects of glycosylation, several analytical technologies have been developed. Additionally, informatics tools play a crucial role in comprehensively understanding glycosylation processes. Therefore, adopting an integrated approach is essential to optimize and ensure consistent production of glycoprotein-based therapeutic drugs. In this article, we examine the most recent advancements and challenges in glycosylation analysis and control within the context of bioprocessing monoclonal antibodies.
Citation: Peiqing Zhang, Susanto Woen, Tianhua Wang, Brian Liau, Sophie Zhao, Chen Chen, Yuansheng Yang, Zhiwei Song, Mark R. Wormald, Chuanfei Yu, Pauline M. Rudd Challenges Of Glycosylation Analysis And Control: An Integrated Approach To Producing Optimal And Consistent Therapeutic Drugs doi:10.1016/j.drudis.2016.01.006
Available online: 25 January 2016
Copyright: © 2016 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.drudis.2016.01.006
Acknowledgments
This work is supported by Biomedical Research Council and Joint Council Office, Agency for Science, Technology and Research (A*STAR), Singapore. The authors would like to thank Corrine Wan and Ce Huang Poo for the technical assistance. Regulatory views in this article are presented by the authors for discussion and considerations. They do not reflect the policy of China Food and Drug Administration (CFDA) or official views of the Chinese Government.
