Monoclonal antibody (mAb) purification requires multiple consecutive steps — capture, intermediate, and polish — typically using chromatography resins. The purification workflow is developed from multiple criteria, to maximize product quality and output. One focus area of process intensification is the reduction of downstream processing (DSP) steps to improve the mAb purification workflow. Mixed-mode resins are increasingly integrated into DSP due to their unique properties and wide design space delivering high purity and yield. These resins consist of multiple modes of interaction that enhance selectivity and separation power.

In this case study, process chromatography application scientist Artur Stanczak presents a two-step mAb purification workflow, comparing multimodal resin alternatives used for the polishing step that occurs after protein A capture. The design of experiment (DOE) data presented characterizes the behavior of multiple mAbs with two different mixed-mode resins. The importance of scale, prior knowledge, and the stage of development will also be discussed. The results of both mixed-mode resin studies and the different DOE approaches demonstrate the ability to achieve high-purity products.

Key Takeaways:

  • Understanding of DOE strategies that may be used in mAb process development, focusing on three phases: screening, modeling, and optimization
  • Assessment of DOE models and tools to leverage (96-well plates, robocolumns, and columns), depending on the development stage
  • Evaluation of the data using mixed-mode resins in a two-step mAb purification workflow

This webinar is presented by Artur Stanzak, Application Specialist in Process Chromatography at Bio-Rad. He received his Master of Science in Biotechnology from the University of Maria Skłodowska-Curie in Lublin, Poland. Experienced in process development, characterization, scale-up, and validation of biologics, Artur supports method development and downstream purification applications.

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