Bispecific Complexity Analytical

Aurigene deployed an analytics-driven strategy to decode an unidentified extra band in a bispecific T-cell engager, using cutting-edge LC-MS for intact mass and subunit-level characterization to localize the clip to a specific heavy-chain residue and rule out homodimer. Two orthogonal cell-based bioassays (TAA-binding on tumor cells and CD3-binding on T-cells) confirmed dual-arm engagement, delivering definitive impurity assignment, process-tunable insight to reduce clipping in subsequent batches, and reproducible functional assays supporting clinical-batch release testing.