Manipulating Polyamines to Enhance Antibody Efficacy: A Novel Approach in Biotechnology
<p>An important CQA for mAbs is the <em>N</em>-linked glycosylation present at a specific position (Asn297). <em>N</em>-linked glycans consist of <em>N</em>-acetylglucosamine (GlcNAc), mannose (Man), fucose (Fuc), galactose (Gal), and sialic acid. The heterogeneity of the <em>N</em>-linked glycan profiles of mAbs can be attributed to the different numbers and linkages of additional saccharides. The composition of <em>N</em>-linked glycans affects the overall therapeutic efficacy, targeting ability, and immune-specificity of these antibodies. For example, antibody-dependent cellular cytotoxicity (ADCC) is influenced by the fucosylation and galactosylation of <em>N</em>-linked glycans. Complement-dependent cytotoxicity (CDC) is also affected by the galactosylation and sialylation of <em>N</em>-linked glycans. Hence, it’s crucial to meticulously regulate <em>N</em>-linked glycan profiles throughout the manufacturing process because the heterogeneity of the <em>N</em>-linked glycan profile of mAbs depends on the cell culture duration and changes in nucleotide sugars and glycosylation enzyme levels.</p>
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