Automatic Assay Preparation Platform (A2P2) for Real-Time Critical Quality Attributes Monitoring of Cell Culture...

Area of Science:

• Biopharmaceutical Manufacturing
• Process Analytical Technology (PAT)
• Biotechnology

Background:

• The biopharmaceutical industry faces intense competition, necessitating faster speed-to-market and "Right First Time" production.
• Current methods for determining critical quality attributes (CQAs) in biotherapeutics involve multiple instruments and significant analyst time.
• Existing analytical workflows for bioprocess monitoring are time-consuming and require extensive laboratory resources.

Purpose of the Study:

• To describe the innovative application of the Automatic Assay Preparation Platform (A2P2) for real-time sample preparation, acquisition, and CQA monitoring in biotherapeutic production.
• To demonstrate how A2P2 streamlines the measurement of titer, product purification, and CQA assays.
• To present A2P2 as an end-to-end automated and autonomous PAT solution.

Main Methods:

• Integration of titer measurement, product purification, concentration measurement, and CQA assay into a single run sequence using a modified ultrahigh performance liquid chromatography (UHPLC) instrument.
• Utilization of Chromeleon's System Suitability Tests (SST) and Intelligence Run Control (IRC) features.
• Leveraging the Agilent injector program for automated sample handling and analysis.

Main Results:

• Significant reduction in analyst hands-on time.
• Substantial shortening of result turnaround time, improving overall efficiency.
• Consolidation of multiple analytical steps onto a single platform, reducing laboratory footprint.

Conclusions:

• The evolved A2P2 system offers an ideal solution for real-time bioprocess monitoring of CQAs.
• This automation accelerates the delivery of safe and effective biotherapeutics.
• A2P2 enhances efficiency and reduces operational complexity in biopharmaceutical manufacturing.