Scalable, Robust and Highly Productive Novel Convecdiff Membrane Platform for mAb Capture.

Area of Science:

• Biotechnology
• Bioprocess Engineering
• Chromatography

Background:

• The capture of monoclonal antibodies (mAbs) using Protein A resins is a critical bottleneck in downstream processing due to diffusion limitations.
• Current Protein A resins necessitate low flow rates, resulting in low productivity (e.g., <30 g L⁻¹ binding capacity) and hindering efficient bioprocessing.

Purpose of the Study:

• To introduce and evaluate a novel chromatography membrane technology designed to enhance mAb capture efficiency and process productivity.
• To demonstrate the scalability and bioprocessing suitability of this new membrane technology across different scales.

Main Methods:

• Development and characterization of a novel chromatography membrane (convecdiff technology) with high binding capacity and flow rates.
• Assessment of scalability using experimental data for various bioprocessing scales.
• Analysis of factors influencing productivity, including residence times, feed titers, and cleaning protocols.

Main Results:

• The novel membrane achieves superior binding capacities and high flow rates, leading to over 10-fold higher productivity compared to Protein A resins.
• Productivity gains are maintained during scale-up, demonstrating the technology's robustness.
• Optimal utilization strategies for the membrane were identified based on feed titer and process parameters, enabling reduced material usage per batch.

Conclusions:

• The convecdiff chromatography membrane technology significantly enhances mAb purification productivity and reduces processing time and material requirements.
• This disposable membrane technology eliminates the need for column handling and resin reuse, streamlining bioprocesses.
• The demonstrated scalability and efficiency make this a promising advancement for industrial mAb purification.