Standardized antibody purification process development workflow using a novel gravity column-based high throughput...

Area of Science:

• Biotechnology
• Biopharmaceutical Manufacturing
• Process Development

Background:

• High-throughput process development (HTPD) is crucial for efficient antibody purification.
• Existing methods using microplates or miniature columns have limitations.
• Faster, cost-effective, and material-efficient purification processes are needed.

Purpose of the Study:

• To introduce a novel HTPD method for antibody purification.
• To demonstrate the method's efficiency in developing purification processes for monoclonal antibodies (mAbs).
• To assess the scalability and product quality of the developed purification method.

Main Methods:

• Utilized optimized gravity columns and liquid-handling workstations for HTPD.
• Developed a three-column purification process for mAbs.
• Scaled up the process from laboratory to pilot scale (50 L cell culture fluid).

Main Results:

• A three-column purification process for mAbs was developed in two days.
• The gravity column method yielded product quality comparable to large-scale columns.
• The HTPD method was successfully applied to a challenging bispecific antibody, demonstrating versatility.

Conclusions:

• The novel HTPD method offers enhanced efficiency and reduced timelines for mAb purification.
• The method is scalable and maintains product quality, making it suitable for industrial application.
• This approach improves the versatility of HTPD for complex biomolecules like bispecific antibodies.