Purification of Antibodies Using Novel Convecdiff Membranes Part 2: Robust Performance at Comparable Product Quality

Convecdiff membranes, a new type of chromatographic material that combines high protein-binding capacity with high productivity while providing scalability, are introduced. The convecdiff membrane prototypes presented in this study reach a dynamic binding capacity of around 40 g/L at residence times in the seconds range while pressure drop is below 2.5 bar at a bed height of several millimeters. The robustness of the new material is proven in two cycling studies with up to 200 cycles. The material performance regarding yield, impurity reduction, etc., observed during cycling is comparable to the performance of established materials, and no performance decline occurred during cycling. Viral clearance by the new membrane was found on par with existing materials. With all these characteristics, the material is well suited for protein bind-and-elute applications ranging from laboratory to production scale.