RealFeedApp CDMOs adopt QbD to shift glycosylation control upstream
Newer antibody therapeutics like bispecific antibodies and ADCs are highly sensitive to glycan heterogeneity, requiring early-stage control of glycosylation processes.
- Field
- medicine and diagnostics
- What they did
- New types of therapeutic antibodies (such as bispecific antibodies and antibody-drug conjugates) are far more sensitive to glycosylation variations than traditional antibodies, so controlling this process must begin at the earliest stages of development rather than being delayed.
- Why it matters
- This is necessary to ensure treatment efficacy and batch-to-batch consistency, as even minor changes in glycosylation structure directly affect how well the drug works in patients.
#glycosylation#biologics#cdmo#antibody therapeutics#quality-by-design
