Specialties

Advanced characterization of complex protein therapeutics, including fusion proteins, mAbs, and ADCs, supporting stability, forced degradation, and CQA assessment

LC-MS approaches to provide deep structural and functional insights for next generation therapeutics

Robust comparability studies to evaluate process, formulation, or scale changes. Using physicochemical characterization, intact mass analysis, and peptide mapping, we generate data-driven insights to demonstrate product consistency and regulatory readiness

End-to-end analytical support for manufacturing challenges. We perform root-cause investigations for aggregation, charge variants, and instability using both targeted and discovery-based mass spectrometry approaches

Comprehensive, submission-ready analytical packages designed to support IND, BLA, and post-approval filings. Our data integrity and documentation practices align with cGMP and global regulatory expectations

Characterization of emerging complex modalities such as Fc-fusions, conjugated proteins, and hybrid biologics beyond traditional platforms