Interest in continuous processing is spreading within the pharmaceutical industry. The feasibility of continuous processing has now been shown at both the process development and the production scale by early adopters. In this study we focus on questions surrounding the ease of process development for continuous monoclonal antibody (mAb) purification and platform versatility.<br/><br/>     We address these questions by challenging the continuous chromatography platform with the purification of four mAbs. The platform comprises three chromatography steps, Protein A capture, anion exchange, and mixed mode cation exchange. Each chromatography step was optimized through a combination of small scale DoE and mathematical modeling. Critical quality attributes such as host cell proteins (HCP) and aggregates are routinely brought to levels below 20 PPM and 1%, respectively. Therefore, the robust purification schemes resulted in products with high yield and purity, including over 4 log reduction of HCP and more than 50% reduction in aggregate protein. Moreover, adapting the continuous chromatography platform to process multiple mAbs proved to be time-efficient, effective and resulted in streamlined and highly productive processes.<br/><br/>     Taken together, these experiments allow us to identify a path toward rapid process development for the continuous chromatography platform, which may drive the use of the continuous processing for clinical manufacturing of mAbs.

Versatility of the continuous chromatography platform

255th National Meeting (2018)

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