Objective:

To develop a high-sensitivity inline Raman measurement system for real-time monitoring of biopharmaceutical manufacturing processes.

Approach:

• System Components: The system integrates a HORIBA Raman spectrometer, a Fujifilm single-use probe, and proprietary measurement algorithms.
• Real-Time Monitoring: It enables continuous analysis of cell culture media and purification solutions without offline testing.
• Technology Application: Raman spectroscopy is used for non-destructive inline chemical analysis during manufacturing.

Key Findings:

• The system improved antibody yield by approximately 10% compared with conventional UV-Vis-based process control methods in demonstration tests using model experimental systems.
• Raman analysis can distinguish antibodies from impurities such as aggregates and fragments, whereas UV-Vis methods generally measure total protein concentration.
• The single-use probe is designed to increase optical throughput while reducing contamination risk and avoiding cleaning steps.

Interpretation:

The system is intended to address a persistent challenge in biomanufacturing: small changes in process conditions can affect product quality and yield, but conventional offline analytics make it difficult to track those changes in real time.

Limitations:

• Further verification work is needed for real-world application.
• The study primarily reports results from model experimental systems.

Conclusion:

The collaboration aims to improve biopharmaceutical quality, process efficiency, and manufacturing costs.