An important CQA for mAbs is the N-linked glycosylation present at a specific position (Asn297). N-linked glycans consist of N-acetylglucosamine (GlcNAc), mannose (Man), fucose (Fuc), galactose (Gal), and sialic acid. The heterogeneity of the N-linked glycan profiles of mAbs can be attributed to the different numbers and linkages of additional saccharides. The composition of N-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 N-linked glycans. Complement-dependent cytotoxicity (CDC) is also affected by the galactosylation and sialylation of N-linked glycans. Hence, it’s crucial to meticulously regulate N-linked glycan profiles throughout the manufacturing process because the heterogeneity of the N-linked glycan profile of mAbs depends on the cell culture duration and changes in nucleotide sugars and glycosylation enzyme levels.
Manipulating Polyamines to Enhance Antibody Efficacy: A Novel Approach in Biotechnology
Monoclonal antibodies (mAbs) are laboratory-designed proteins that mimic the immune system’s antibodies. To date, many therapeutic mAbs belonging to the immunoglobulin G (IgG) class…