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Updated: Feb 16, 2026

Laboratory Scale Production and Purification of a Therapeutic Antibody

Laboratory Scale Production and Purification of a Therapeutic Antibody

Published on: January 24, 2017

Integrated flow-through purification for therapeutic monoclonal antibodies processing.

Takamitsu Ichihara¹, Takao Ito², Yasuhiko Kurisu²

¹a Astellas Pharma Inc. 2-5-1, Nihonbashi-Honcho , Chuo-ku , Tokyo , Japan.

|December 23, 2017

Summary

A new all flow-through purification platform using activated carbon and chromatography offers superior monoclonal antibody (mAb) impurity removal and high yields. This advanced technology improves facility use and process economics.

Keywords:

activated carbon continuous manufacturing flow-through chromatography integrated process monoclonal antibody purification

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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.