mAb Purification Process Development Using Mixed-Mode Resins - The DOE Approach

A monoclonal antibody (MAb) purification process involves multiple consecutive steps, typically using three chromatography resins. These three purification steps are referred to as capture, intermediate, and polish. The workflow is based on multiple criteria to maximize product quality and output, including process efficiencies. One focus area of process intensification is reducing the downstream processing (DSP) steps to improve the MAb purification workflow.
Mixed-mode resins are being increasingly integrated into DSP due to their unique properties and wide design space that delivers high purity and yield. These resins consist of multiple modes of interaction that enhance selectivity and separation power.
This case study presents a two-step MAb purification workflow and the comparison of two multimodal resin alternatives used for the polishing step post-protein A capture step. Data will be presented that studies the behavior of multiple MAbs with these two different mixed-mode resins and the design of experiments (DOE). The importance of scale, prior knowledge, and the development stage will also be discussed. The results of both mixed-mode resin studies and their different DOE approaches to development will show the ability to achieve high-purity products.
Key Takeaways:
• Understanding of DOE strategies in process development - three phase strategy - screening, modeling, and optimization.
• Assessment of DOE models and tools to select (96 well plates, robocolumns, and columns) depending on development stage.
• Evaluation of the data using mixed-mode resins in a two-step MAb purification workflow.
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