The biopharmaceutical industry is on the cusp of a significant transformation through the integration of automated sterile sampling technologies. Leading companies such as Pfizer and Eli Lilly are actively collaborating to enhance process control and reduce development timelines in biopharmaceutical manufacturing. This shift is crucial as the sector grapples with the challenge of maintaining sterility while obtaining critical process data directly from bioreactors.
The Need for Reliable Sampling Systems
In contrast to the well-established online sampling methodologies prevalent in the chemical, food, and small-molecule pharmaceutical industries, the biopharmaceutical sector still lacks a dependable system for transferring samples directly from bioreactors to analytical devices without compromising sterility. This gap hampers companies’ ability to leverage process analytical technology (PAT) effectively, which is essential for gaining insights into bioreactor operations. Although techniques like Raman and dielectric spectroscopy contribute valuable data, the integration of this information with off-line measurements—such as cell viability, metabolite levels, and titers—remains imperative.
The MAST Platform: A Breakthrough Solution
To address these challenges, Bend Research, a recent Capsugel acquisition, has partnered with several major biopharmaceutical organizations to create the Modular Automated Sampling Technology (MAST) platform. This innovative system features a sterile sampling unit, an automated sample scheduling and navigation component, and a robust data management system designed to optimize sample collection and analysis. Notably, the MAST platform allows for real-time feedback to bioreactors, enabling immediate adjustments to reaction conditions.
Sterile Sampling Made Possible
At the core of the MAST platform lies the Sample Pilot—a new sterile sampling unit composed of a sampling module and a programmable logic controller (PLC). The platform includes two variants: the SP100, which collects 50-mL samples for larger-scale operations, and the SP200, designed for smaller-scale laboratory and pilot bioreactor reactions. Each module utilizes proprietary valves and a pump system, allowing for the efficient transfer of samples, even those with high cell densities, over considerable distances.
Both the SP100 and SP200 systems can be sterilized in place, autoclaved, or gamma-sterilized based on user preferences. This flexibility empowers users to maintain sterility between samples while tailoring cleaning procedures to meet their specific operational requirements.
Comprehensive Sample and Data Management
To harness the full potential of sterile biopharmaceutical sampling, the MAST platform incorporates sophisticated software for managing sample scheduling and delivery, as well as processing analytical results. The Sample Scheduler and Navigator modules work synergistically to facilitate sample collection from multiple bioreactors, directing samples to various analytical systems. This user-friendly interface supports integration with third-party analyzers, streamlining the analytical process.
The data management component of the MAST platform not only keeps track of sampling activities and analysis results but also has the capability to adjust bioreactor feed rates in real time to optimize cell growth. This rapid processing of analytical results allows researchers to focus on higher-value activities, thus increasing overall productivity.
Proven Performance in Real-World Applications
The efficacy of the MAST platform has been validated through extensive testing. The SP100 module has been successfully utilized in 130-L and 500-L bioreactors for producing regulatory toxicology supplies, demonstrating its ability to deliver over 300 contamination-free samples during extensive operational periods. The SP200 has also been deployed successfully across various facilities, with rigorous testing ensuring its reliability and long-lasting performance.
Enhancing Process Analytics
Initial studies have shown that the MAST system’s automated at-line measurements closely mirror those obtained through traditional manual sampling methods. Integration with on-line analytical technologies enables comprehensive monitoring of cell health and bioprocess conditions in real time. For example, dielectric spectroscopy data can be refined to provide accurate estimates of cell density, while off-line measurements like Raman spectroscopy can be collected more frequently, enhancing the dataset for process monitoring models.
Progressing Toward Commercialization
The MAST system is currently in beta testing, with ongoing evaluations at numerous pharmaceutical and biotechnology companies. The objective is to finalize the technology for commercialization while collaborating with various vendors for physical components and software integration. Tailoring the platform to meet specific manufacturer needs, particularly in the context of preferred analytical techniques, remains a priority.
Real Advantages for Manufacturers
The MAST platform presents several compelling advantages for biopharmaceutical manufacturers. By facilitating more frequent and reproducible sampling without operator involvement, it minimizes contamination risks and operator exposure. Furthermore, integrating diverse analytical results offers deeper insights into cellular behavior and process parameters, fostering the adoption of more advanced process control strategies.
The ultimate goal of the MAST platform is to provide biopharmaceutical companies with critical insights into bioreactor dynamics, thus enhancing product quality. By equipping manufacturers with the necessary tools for real-time analytics and process measurements, the MAST platform aims to drive consistent product quality and batch reproducibility.
Conclusion
The advent of automated sterile sampling technology marks a pivotal moment for the biopharmaceutical industry. The MAST platform not only addresses existing gaps in sampling reliability but also paves the way for enhanced process understanding and control. As this technology progresses toward widespread adoption, it holds the potential to revolutionize biopharmaceutical manufacturing, delivering significant benefits in efficiency and product consistency.
- The MAST platform enhances sterile sampling in biopharmaceutical manufacturing.
- It incorporates real-time data management to optimize bioreactor conditions.
- Successful testing has demonstrated the system’s reliability across various scales.
- Integration with existing analytical technologies broadens process insights.
- Automation reduces contamination risks and operator exposure.
Source: www.pharmtech.com