As biologics pipelines diversify beyond conventional monoclonal antibodies into bispecifics, antibody-drug conjugates, and Fc-fusion proteins, glycosylation control is shifting upstream rather than being addressed downstream. As a majority of glycan variability is clone-dependent, early clone selection with molecule-specific analytics is essential to ensuring both titer and glycan quality from the outset. Upstream parameters such as temperature, pH, and substrate modulation can be intentionally designed to influence glycosylation outcomes, while design-of-experiments methodologies and real-time monitoring align with ICH Q8/Q11 guidelines.
Read the full interview with Sojeong Lee, Director of Upstream Development, at The Medicine Maker.
As biologics pipelines diversify beyond conventional monoclonal antibodies into bispecifics, antibody-drug conjugates, and Fc-fusion proteins, glycosylation control is shifting upstream rather than being addressed downstream. As a majority of glycan variability is clone-dependent, early clone selection with molecule-specific analytics is essential to ensuring both titer and glycan quality from the outset. Upstream parameters such as temperature, pH, and substrate modulation can be intentionally designed to influence glycosylation outcomes, while design-of-experiments methodologies and real-time monitoring align with ICH Q8/Q11 guidelines.
Read the full interview with Sojeong Lee, Director of Upstream Development, at The Medicine Maker.
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