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Updated: Jan 15, 2026

Laboratory Scale Production and Purification of a Therapeutic Antibody

Laboratory Scale Production and Purification of a Therapeutic Antibody

Published on: January 24, 2017

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

Yugang Li¹, Na Liu¹

¹Downstream Process Development (DSPD), WuXi Biologics, Waigaoqiao Free Trade Zone, Shanghai 200131, China.

Journal of Chromatography. A

|October 10, 2025

Summary

This summary is machine-generated.

A new high-throughput process development (HTPD) method using gravity columns accelerates antibody purification. This HTPD approach significantly reduces timelines and costs for monoclonal antibody development.

Keywords:

Antibody Gravity column High-throughput Process development Scale-up

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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.