Keeping mAb Aggregation Low During The Final UF/DF Step

Monoclonal antibody aggregation remains a critical concern throughout downstream processing and final formulation, with direct implications for product quality and patient safety. Aggregates can form under a range of stresses, from shear and heat to changes in solution chemistry and material interactions. Risk often increases as mAbs are concentrated during UF/DF and transitioned into their final formulation buffer, where viscosity and protein–protein interactions become harder to control. Molecular characteristics such as charge, flexibility, and hydrophobicity further influence aggregation behavior, while equipment choices—including pumps, TFF cassettes, and recirculation vessels—can either amplify or reduce stress. Understanding how process conditions, system design, and material selection intersect is essential for maintaining low aggregate levels, particularly for unstable or high‑concentration mAbs.

Learn how thoughtful process and equipment optimization can help protect molecule integrity during chromatography and TFF.