Optimizing Bioprocessing with Raman Technology & Catalyx OpenBIO® Open Architecture Bioreactor Controller
Overview
A pharmaceutical company integrated over 30 Endress+Hauser Raman analyzers across multiple sites—including in Pennsylvania—enhancing both operational efficiency and process precision. With Rxn2 analyzers deployed in labs and Rxn4 units in cGMP production, the rollout demonstrated the transformative potential of Raman technology.
Catalyx OpenBIO’s out-of-the-box PAT integration made incorporating Raman Rxn-10 probes seamless, enabling more accessible and actionable PAT data. By leveraging Catalyx’s PAT-ready capabilities, the company achieved real-time feed rate adjustments, optimizing cell growth conditions and ensuring consistent bioprocess performance.
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
Before OpenBIO, bioreactor users struggled to convert real-time process data into actionable insights, hindering the adoption of Raman and PAT technologies. The absence of seamless integration required users to manually input data into the bioreactor control system, preventing companies from fully leveraging their PAT investments and realizing the expected return.
Our Solution
To overcome these challenges, the pharmaceutical company adopted the Catalyx OpenBIO® Open Architecture Bioreactor Controller. Leveraging its out-of-the-box PAT integration capability, the system was seamlessly connected with Endress+Hauser’s Raman Rxn2 and Rxn4 analyzers, as well as Rxn-10 probes. This powerful combination enabled real-time, continuous manufacturing with precise control over bioprocess parameters.
OpenBIO® facilitated automated, data-driven process adjustments by using 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 significantly enhanced scalability, consistency, and compliance across R&D, process development, and production environments.
Step 1: Seamless Integration of Optical Analysis for Real-Time Bioprocess Control
- Integrated Endress+Hauser’s optical analysis instruments with Catalyx’s platform to enhance operational efficiency and ROI.
- Enabled instant glucose level monitoring and automated feed rate adjustments, ensuring optimal cell growth in real time.
Step 2: Streamlined Recipe Execution for Scalable Bioprocessing
- Deployed OpenBIO® for automated recipe execution across HMIs, tablets, and mobile devices.
- Simplified tech transfer between R&D and manufacturing, optimizing scale-up efficiency and bioprocess operations.
Step 3: Implemented Software for Flexible, Data-Driven Batch Control
- Integrated standardized software with customizable algorithms, ensuring greater adaptability.
- Leveraged S88 recipe-driven automation to enhance batch control, data collection, and process integrity.
Step 4: Ensured Comprehensive Reporting & Versatile Analysis
- Utilized the Raman Rxn2 analyzer to provide transparent process reporting and audit trails.
- Enabled seamless model transfer for routine sample identification, R&D support, and scale-up applications.
Step 5: Integrated Real-Time Process Monitoring & Control
- Deployed Raman Rxn2 and Rxn4 analyzers to enable high-resolution process monitoring across R&D, process development, and manufacturing.
- Implemented real-time, in situ measurements via touchscreen and remote access, while the Rxn4 featured self-monitoring and diagnostics for precise process control.
Step 6: Optimized Space Utilization & Enhanced Process Monitoring
- Used the stackable 19-inch Raman Rxn4 analyzer to maximize production floor space, with an optional NEMA 4X stainless steel enclosure for added durability.
- Integrated Raman Rxn-10 probes to improve process development with high-performance monitoring.
Step 7: Deployed Versatile & High-Performance Raman Measurement
- Utilized the Raman Rxn-10 probe for high-sensitivity Raman analysis across a wide spectral range, supporting solids and liquids analysis.
- Enabled seamless integration with Near-Infrared (NIR) spectroscopy and real-time data exchange via OPC UA, ensuring accurate measurement and process control.
- Integrated built-in laser safety interlocks to ensure safe operation across diverse environments.
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 OpenBIO® 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.