Platform strategy for improving manufacturability and efficacy in bispecific antibodies

Bispecific antibodies (bsAbs) offer significant therapeutic potential, but their complex molecular architecture introduces greater manufacturability and developability challenges than conventional monoclonal antibodies. Balancing manufacturability with critical quality attributes (CQAs) remains a central challenge in bsAb development. 

This whitepaper explores how Samsung Biologics' S-DUAL® platform integrates molecular engineering strategies to improve heavy chain-heavy chain (HC-HC) and heavy chain-light chain (HC-LC) assembly fidelity, enabling high product purity, robust expression yields, favorable stability, and compatibility with scalable manufacturing while preserving biological performance. 

Key highlights include:

• An integrated engineering strategy that improves HC-HC and HC-LC assembly fidelity 

• High product purity, robust expression yields, and favorable stability supporting scalable manufacturing 

• Preserved target-binding activity and HER2-associated signaling inhibition 

• Meaningful antiproliferative activity across multiple HER2-positive cell models 

• An antibody engineering framework that integrates developability and functionality within a single platform 

Discover how integrated antibody engineering strategies can improve manufacturability while preserving therapeutic performance for next-generation bispecific antibody development.