Development Of A Drop-In Purification Step For Removal Of Aggregates From An Antibody Therapeutic

A client was engaged in large scale cGMP manufacturing operations at a major CMO and their product contained high levels of aggregate following an affinity capture step. Subsequent chromatography steps reduced the aggregate level to acceptable levels but product losses were encountered in elution buffers, and stat in-process assays. Read how they were able to reduce aggregate level and simplify the downstream purification process.