Pharma Focus Asia

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:

Glycosylation of therapeutic proteins has a profound impact on their safety and efficacy. Many factors shape the glycosylation of biotherapeutics, ranging from expression systems and cell culture processes to downstream purification strategies. Various analytical technologies have been developed to address questions concerning different aspects of glycosylation. Informatics tools are also crucial for a systematic understanding of the glycosylation processes. Hence, an integrated approach is required to harness glycosylation for the production of optimal and consistent glycoprotein-based therapeutic drugs. Here, we review the latest developments and challenges in glycosylation analysis and control in 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.

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