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Core analytical requirements include: Primary structure confirmation using LC-MS/MS to verify intact mass, sequence integrity and detect modifications Impurity profiling (e.g., sequence variants, degradation products) using high-resolution techniques such as UHPLC-HRMS Aggregation and molecular weight analysis using orthogonal methods like SEC-MALS and sedimentation velocity analytical ultracentrifugation (SV-AUC)

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Just like a car, we need to ensure the engine can handle the higher revs before we hit the gas