Peptide, peptide‑conjugated, and other complex modalities present unique CMC challenges. These programs require mechanism‑aligned characterization of biological activity, structural integrity, and impurity‑related functional risk.

Leveraging experience from more than 450 product‑specific potency assays and over 300 therapeutic targets, WuXi Biologics has established a bioassay tailored for peptide therapeutics. Their  approach incorporates signaling assays based on G protein–coupled‑receptors, engineered reporter gene systems, real-time binding analysis using surface plasmon resonance, and Fc effector function profiling.

Together, these capabilities provide MOA-relevant assessment, accelerate CMC development, and help reduce regulatory risk.

Key takeaways:

• Explore advanced bioassay solutions to address regulatory and impurity control challenges in CMC.

• Understand tailored bioassay strategies for complex MOAs and next-generation peptide modalities.

• Review a GLP-1 therapeutics case study highlighting WuXi Biologics’ technical expertise and excellence in regulatory compliance and program execution.