Glycan mapping of glycotherapeutics.
Glycosylation of proteins may, or may not, affect biological activity, either directly or indirectly. In addition, variability in glycosylation arises within the manufacturing procedure. Therefore, glycosylation would be an important parameter when assessing product quality. Regulatory authorities require biotechnological and biological products to be characterised, including determination of their biological activity, physicochemical and immunochemical properties, their purity and their impurity profiles. Here we outline how we can decide if and which types of glycan analysis and methodologies to use for glycoprotein therapeutics to answer the scientific questions as well as meeting regulatory requirements that already exist or are going to be developed/implemented.
Yuen
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CT
National Institute for Biological Standards and Control, Blanche Lane, South Mimms, EN6 3QG Hertfordshire, UK. cyuen@nibsc.ac.uk
Bristow
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A
Jones
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C
D000911:Antibodies, Monoclonal / Q000032:analysis / Q000627:therapeutic use; D016207:Cytokines / Q000032:analysis / Q000627:therapeutic use; D006023:Glycoproteins / Q000032:analysis* / Q000627:therapeutic use*; D006031:Glycosylation; D011994:Recombinant Proteins / Q000032:analysis / Q000627:therapeutic use; D014612:Vaccines / Q000032:analysis / Q000627:therapeutic use
D000911:Antibodies, Monoclonal; D016207:Cytokines; D006023:Glycoproteins; D011994:Recombinant Proteins; D014612:Vaccines