Automated quality analysis in continuous downstream processes for small-scale applications

Area of Science:

• Biopharmaceutical Manufacturing
• Process Analytical Technology
• Chromatography

Background:

• Integrated, continuous biomanufacturing (ICB) requires efficient data acquisition for monitoring, quality testing, and control.
• Manual sample handling introduces time delays, labor costs, and human error, hindering process development and control.

Purpose of the Study:

• To develop an automated quality analysis system (QAS) for sample acquisition, preparation, and analysis in small-scale biopharmaceutical downstream processes.
• To enable automated process monitoring and data-based control in continuous biomanufacturing.

Main Methods:

• Developed an automated quality analysis system (QAS) integrating ÄKTA Explorer for sample handling and Agilent 1260 Infinity II HPLC for analysis.
• Utilized Python-based Orbit software for system control and communication.
• Demonstrated QAS with a continuous capture chromatography process for monoclonal antibody purification.

Main Results:

• The QAS successfully automated sample collection, preparation, and analysis during a continuous capture chromatography run.
• Consistent quality process data was acquired without human intervention.
• Enabled determination of aggregate content and charge variant composition via SEC and IEX chromatography.

Conclusions:

• The developed QAS effectively addresses challenges in data acquisition for ICB processes.
• Automation reduces manual labor and variability, paving the way for enhanced process monitoring and control.
• The system supports real-time quality assessment crucial for biopharmaceutical production.