Integrated flow-through purification for therapeutic monoclonal antibodies processing.

Area of Science:

• Biotechnology
• Chemical Engineering
• Pharmaceutical Manufacturing

Background:

• Conventional chromatography platforms for therapeutic monoclonal antibody (mAb) purification are often complex and resource-intensive.
• There is a continuous need for more efficient and economical purification strategies in biopharmaceutical manufacturing.

Purpose of the Study:

• To develop and evaluate an integrated all flow-through technology platform for mAb purification.
• To assess the impurity clearance, yield, and loading capacity of the novel platform compared to conventional methods.

Main Methods:

• The platform integrates activated carbon, flow-through cation exchange, and anion exchange chromatography steps.
• High-throughput 96-well plate screening was employed for process optimization, focusing on mAb loading and solution conditions.

Main Results:

• The integrated platform demonstrated excellent impurity clearance, including DNA, host cell protein, and mAb aggregates, at high mAb loadings.
• Overall mAb yield exceeded 80%, with a ten-fold improvement in mAb loading capacity compared to traditional bind-and-elute cation exchange resins.
• High monomer recoveries were achieved alongside robust aggregate removal.

Conclusions:

• The all flow-through purification platform offers a viable and advantageous alternative to conventional chromatography for mAb purification.
• This approach presents significant opportunities for enhanced facility utilization and improved process economics in biopharmaceutical manufacturing.