Abstract

AbstractAntibody products are promising therapeutic candidates for various diseases, such as cancers and autoimmune disorders. Owing to the improvement of cell culture technology in recent years, the production titers of antibodies can reach up to 10 g/L. With such high titers in upstream production, advancements in the development of downstream separation and purification techniques are highly desired. To ensure a balance between handling the increased product supply and maintaining the high purity required for biopharmaceutical applications, membrane chromatography is an efficient and cost-effective technique that can be used to separate and purify proteins and other biological components. In this study, we developed a full-membrane platform that uses affinity membrane chromatography to capture antibodies, which is followed by a two-step flow-through polishing process involving anion exchange membrane chromatography and hydrophobic interaction membrane chromatography. We tested five molecules using this platform, and the outcomes of membrane chromatography were comparable to those of column chromatography in terms of yield and product quality. Moreover, full-membrane chromatography might lead to a cost reduction of > 70% in chromatography media. Altogether, the full-membrane platform developed in this has potential applications in downstream processes of antibody production.

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