Safeguarding Function Through Scale-Up

Functional profiling ensures consistency beyond structural analytics.

During transition from small-scale to large-scale antibody production, glycosylation changes were detected, but comprehensive Fc profiling confirmed functional consistency across manufacturing lots. By validating effector activity directly, our platform de-risks scale-up and preserves the intended therapeutic profile as production scales.

• Confirmed effector function despite glycosylation shifts across lots
• Added critical functional validation beyond standard structural assays
• Supports end-to-end confidence from development through manufacturing
  

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