Overview

A pharmaceutical company integrated 30+ Endress+Hauser Raman analyzers across multiple sites, including Pennsylvania, enhancing operational efficiency and precision. With Rxn2 analyzers in labs and Rxn4 in cGMP production, the deployment showcased Raman technology’s transformative potential. Catalyx OpenBIO Bioreactor Control’s out-of-the-box PAT integration capability made incorporating Raman Rxn-10 probes a seamless task, making the PAT data more accessible and actionable. Leveraging Catalyx’s PAT-ready capability, the company enabled real-time feed rate adjustments, optimizing cell growth conditions and ensuring bioprocess consistency.

Challenges

Manual Sampling Inefficiencies: Reliance on manual sample extraction and lab analysis for bioreactor adjustments led to delays, contamination risks, and inefficiencies. Real-time integration was needed, but cost and complexity concerns hindered adoption.

Data Integration Barriers: In the pre-OpenBIO days, bioreactor users struggled to convert real-time process data into actionable insights, limiting the adoption of Raman and PAT technology. The lack of seamless integration meant users had to manually enter the data in the bioreactor control system which prevented companies from fully leveraging this technology and realizing the returns on their sizable investments made in installing a PAT system.

Solution

To overcome these challenges, the pharmaceutical company adopted the Catalyx OpenBIO® Bioreactor Controller and, using its out-of-the-box PAT integration capability, seamlessly integrated with Endress+Hauser’s Raman Rxn2 and Rxn4 analyzers and Rxn-10 probes. This powerful combination enabled real-time, continuous manufacturing, providing precise control over bioprocess parameters. The Catalyx OpenBIO® platform ensured automated, data-driven process adjustments, leveraging Raman spectroscopy to monitor critical quality attributes (CQAs) such as glucose concentration, nutrient levels, and metabolic activity. By eliminating manual sampling delays and inefficiencies, the system enhanced scalability, consistency, and compliance across R&D, process development, and production environments.

Steps

1: Seamless Integration of Optical Analysis for Real-Time Bioprocess Control

2: Streamlined Recipe Execution for Scalable Bioprocessing

3: Implemented Software for Flexible, Data-Driven Batch Control

4: Ensured Comprehensive Reporting & Versatile Analysis

5: Integrated Real-Time Process Monitoring & Control

6: Optimized Space Utilization & Enhanced Process Monitoring

7: Deployed Versatile & High-Performance Raman Measurement

Note: Versatile & High-Performance Raman Measurement

The Raman Rxn-10 probe delivers high-sensitivity Raman analysis across a wide spectral range, making it ideal for solids and liquids analysis. Its compact, lightweight design supports interchangeable optics, enabling seamless adaptation for non-contact, immersion, and bioprocessing applications.

Designed for life sciences, chemical, and food beverage industries, it integrates Near-Infrared (NIR) spectroscopy, supports real-time data exchange via OPC UA, and ensures accurate measurement and process control. Built-in laser safety interlocks enhance safe operation across diverse environments.

Outcomes

Eliminated Manual Sampling

By implementing the Catalyx OpenBIO® Bioreactor Controller with Raman analyzers and probes, the pharmaceutical company eliminated manual sampling, reducing contamination risks and enhancing operational efficiency. This automated, real-time monitoring ensured precise process control, improved accuracy, consistency, and compliance, and streamlined production.

Accelerated Batch Processing: 7 Days to 3 Days

Real-time monitoring and control enabled faster, more efficient batch processing, reducing batch time from seven days to three—increasing throughput, productivity, and overall operational efficiency.

$300K ROI Per Unit Annually

Enhanced yield optimization and increased batch throughput resulted in an ROI of approximately $300,000 per unit per year, driving significant financial and operational gains.

Optimized Production Through Real-Time Process Control

By shifting from passive monitoring to active process control with Raman analyzers and probes, the pharmaceutical company achieved real-time control at a manufacturing scale for FDA-approved products. This advancement was essential for optimizing production, ensuring process consistency, and maintaining superior product quality.

Global Harmonization & Model Transferability

By leveraging models and equipment from European sister sites, the project demonstrated “model transferability,” enabling consistent and efficient process replication across global locations.

Conclusion

The implementation of the Catalyx OpenBIO® Bioreactor Controller with Raman analyzers and probes transformed operational efficiency, eliminating manual sampling, reducing contamination risks, and cutting batch time from seven to three days. This boost in efficiency maximized yields and throughput, delivering an ROI of $300K per unit annually.

By shifting from monitoring to active process control, the pharmaceutical company successfully scaled FDA-approved products, optimizing production and quality consistency. Additionally, the project demonstrated global model transferability, enabling efficient process replication across multiple locations, ensuring standardized and scalable bioprocessing worldwide.