Design and control of integrated chromatography column sequences.

Area of Science:

• Chemical Engineering
• Biotechnology
• Biopharmaceutical Manufacturing

Background:

• Increasing productivity in biopharmaceutical production is crucial.
• Integrated continuous biomanufacturing offers advantages like reduced tankage and automation.
• Downstream processing is a key area for optimization.

Purpose of the Study:

• To present a methodology for the design and control of downstream processes using integrated column sequences.
• To facilitate the transition from batch separations to integrated separation sequences.
• To demonstrate the application of this methodology in a case study.

Main Methods:

• Development of a four-step methodology for integrated column sequence design and control.
• Utilization of a set of tools to simplify the transition from batch to integrated processes.
• Implementation and illustration on a case study involving tertiary protein separation.

Main Results:

• Successful design and control of an integrated column sequence for a tertiary protein separation.
• Demonstration of an efficient drug development platform for small-scale production using integrated column sequences on a single chromatography system.
• Validation of the proposed methodology and its associated tools.

Conclusions:

• The presented methodology enables efficient design and control of integrated downstream processes.
• Integrated column sequences are a viable and efficient approach for biopharmaceutical production, particularly for small-scale applications.
• The methodology simplifies the implementation of continuous biomanufacturing principles.