Assessment of the HaLCon® Protein Analyzer for At-Line Titer Measurements in Biomanufacturing Applications.

Purpose: With the increasing demand for intensified processes in biopharmaceutical manufacturing, there is a growing requirement for a rapid and precise analytical method to measure product yield. Aligning with FDA guidelines, this requirement aims to enhance process monitoring and control. Currently, the monitoring of monoclonal antibody (mAb) titer during manufacturing heavily relies on offline testing conducted in quality control laboratories. However, the lengthy turnaround time for analytical results, often taking hours or even days, undermines their usefulness for process control and decision-making. Methods: This manuscript presents a case study on HaLCon® protein analyzer, a compact Liquid Chromatography (LC) system equipped with a Protein A affinity column. HaLCon® is specifically designed for at-line/on-line titer measurement directly at the biopharmaceutical manufacturing site, enabling the rapid acquisition of product yield information. The study investigates the capabilities, performance, and potential applications of HaLCon® at the laboratory scale. Results and Conclusion: The results obtained demonstrate the effectiveness and reliability of HaLCon® as an analytical instrument for at-line titer measurement, offering valuable insights into its potential application within the biopharmaceutical manufacturing industry. [ABSTRACT FROM AUTHOR]