Optimizing Charge And N-glycan Profiles For CHO-Derived Fusion Proteins

By Sojeong Lee, Director of Upstream Development; and Gyubeom Chin, Associate Director of USP Platform

For recombinant biologics such as monoclonal antibodies, fusion proteins, and bispecifics, product quality attributes like charge variant distribution and glycosylation play a critical role in determining efficacy, clearance, and immunogenicity. As molecular formats increase in complexity, maintaining consistent control over these attributes is essential to achieving the desired target product profile. Design-of-experiment (DoE) studies provide a powerful framework for developing process understanding and establishing robust manufacturing strategies that drive product quality.

At Samsung Biologics, DoE-based approaches enabled measurable improvements in key quality parameters, including a 7% reduction in acidic charge variants, a 25% reduction in basic charge variants, and shifts toward desired glycoforms such as afucosylation, galactosylation, and high-mannose. Case studies with a bispecific Fc fusion protein and an Fc fusion further demonstrate how this systematic methodology delivers enhanced product consistency and therapeutic potential.

Learn how structured process optimization can improve biologics quality and accelerate development success.