Why Glycosylation Control Is No Longer a Secondary Concern in the Development of Complex Biologics
AI summary
Glycosylation control is shifting from a secondary analytical concern to a core development priority for complex biologics. This changes expectations for contract development and manufacturing organizations, which are now being asked to address glycosylation earlier rather than after the fact. The article presents quality-by-design methods as a way for CDMOs to move these controls upstream efficiently, making process development more proactive and better aligned with complex biologic requirements.
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