Advances in molecular biology have led to cell culture titer increases to =10 g/L. Such increase can pose concern to traditional downstream purification process because of limitations in column hardware and binding capacity of protein A resins. Recent development of high capacity cation exchangers makes cation exchange chromatography (CEX) a promising alternative to directly capture antibody from a high titer process. However, successful use of CEX is more reported in case-specific studies rather as a routine method for mAb production. This is due to the fact that the process performance of CEX is highly dependent on the specific properties of the resins and molecules. Our work investigates the feasibility of applying CEX as a platform capture step. Seven newer generation CEX resins were evaluated for binding capacity and selectivity using a panel of monoclonal antibodies. A relatively wide range of antibody pI (~6.5-8.5) was built into the evaluation matrix. First step involved selection of high-capacity candidate resins with high tolerance to salt concentration and the change of antibody pI. Subsequent studies were done to optimize the loading and elution conditions with the design of experiments approach.

Evaluation of high-capacity cation exchange resins for direct capture of monoclonal antibodies in high-titer purification processes

245th National Meeting (2013)

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