title: Challenges of glycosylation analysis and control: an integrated approach to producing optimal and consistent therapeutic drugs.
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.
authors.affiliation: Bioprocessing Technology Institute, 20 Biopolis Way, #06-01 Centros, Singapore; National University of Singapore, 21 Lower Kent Ridge Road, Singapore.
authors.forename: Peiqing
authors.initials: P
authors.lastname: Zhang
authors.affiliation: Bioprocessing Technology Institute, 20 Biopolis Way, #06-01 Centros, Singapore.
authors.forename: Susanto
authors.initials: S
authors.lastname: Woen
authors.affiliation: Bioprocessing Technology Institute, 20 Biopolis Way, #06-01 Centros, Singapore.
authors.forename: Tianhua
authors.initials: T
authors.lastname: Wang
authors.affiliation: Bioprocessing Technology Institute, 20 Biopolis Way, #06-01 Centros, Singapore.
authors.forename: Brian
authors.initials: B
authors.lastname: Liau
authors.affiliation: Bioprocessing Technology Institute, 20 Biopolis Way, #06-01 Centros, Singapore.
authors.forename: Sophie
authors.initials: S
authors.lastname: Zhao
authors.affiliation: Bioprocessing Technology Institute, 20 Biopolis Way, #06-01 Centros, Singapore.
authors.forename: Chen
authors.initials: C
authors.lastname: Chen
authors.affiliation: Bioprocessing Technology Institute, 20 Biopolis Way, #06-01 Centros, Singapore.
authors.forename: Yuansheng
authors.initials: Y
authors.lastname: Yang
authors.affiliation: Bioprocessing Technology Institute, 20 Biopolis Way, #06-01 Centros, Singapore; National University of Singapore, 21 Lower Kent Ridge Road, Singapore.
authors.forename: Zhiwei
authors.initials: Z
authors.lastname: Song
authors.affiliation: Oxford Glycobiology Institute, South Parks Road, Oxford OX1 3QU, UK.
authors.forename: Mark R
authors.initials: MR
authors.lastname: Wormald
authors.affiliation: National Institutes for Food and Drug Control, No. 2, Tiantan Xili, Dongcheng District, Beijing, China.
authors.forename: Chuanfei
authors.initials: C
authors.lastname: Yu
authors.affiliation: Bioprocessing Technology Institute, 20 Biopolis Way, #06-01 Centros, Singapore; NIBRT GlycoScience Group, NIBRT - The National Institute for Bioprocessing Research and Training, Fosters Avenue, Mount Merrion, Blackrock, Co. Dublin, Ireland. Electronic address: pauline.rudd@nibrt.ie.
authors.forename: Pauline M
authors.initials: PM
authors.lastname: Rudd
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000494:pharmacology; D002460:Cell Line; D055808:Drug Discovery; D006023:Glycoproteins / Q000378:metabolism; D006031:Glycosylation; D006801:Humans
chemical_list: D000911:Antibodies, Monoclonal; D006023:Glycoproteins