Monoclonal antibodies (mAbs) represent nearly half of the biologic-based therapeutics available on the market. While mAbs have revolutionized modern medicine by providing increased efficacy and reducing off target side-effects, downstream purification of mAbs remains highly challenging and represents the largest cost in manufacturing this class of therapeutics. Herein, a downstream process methodology for rapid purification of mAbs is presented. Through use of pre-absorption filtration technology in combination with newly developed Protein A and anion exchange chromatography resins that possess high dynamic binding capacities, we have obtained mAbs with increased purity while reducing overall process time. Furthermore, by using select additives during process chromatography, we demonstrate that these resins can be fine-tuned to enhance selectivity of target mAbs and remove host cell protein impurities. When used in conjunction these technologies represent a highly efficient process to obtain mAbs for use as therapeutics.

Development of an improved downstream process for enhanced monoclonal antibody purification

2019 Spring National Meeting

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