Key Findings
Lonza’s OptiALTO™ platform is dramatically enhancing biopharmaceutical production yields in high-cell-density cultures by effectively integrating Raman spectroscopy as a Process Analytical Technology (PAT). This innovative approach allows for real-time monitoring of nutrient and metabolic activity, optimizing the culture process, which consequently maximizes yield per batch and significantly improves the productivity of manufacturing assets. This marks a critical advancement in boosting the efficiency and economics of biopharmaceutical manufacturing.
Technical / Clinical Details
- OptiALTO™ Platform: Lonza’s OptiALTO™ is a manufacturing platform based on intensified fed-batch strategies, designed to optimize cell culture processes and achieve higher cell densities and productivity. This platform enables the production of more product with a smaller footprint compared to traditional batch processes.
- Raman Spectroscopy as PAT: Raman spectroscopy is a key PAT tool integrated into the OptiALTO™ platform. This non-invasive technique allows for continuous, real-time measurement of critical nutrients and metabolites, such as glucose, lactate, and ammonia, present in the bioreactor medium. This capability provides operators with constant insight into the process state, enabling rapid adjustments as needed.
- Real-time Monitoring and Process Control: Real-time monitoring of nutrient and metabolic activity via Raman spectroscopy offers invaluable information for dynamically adjusting feed strategies and optimizing cell growth and product generation. This minimizes variations in culture conditions, ensuring product consistency and quality.
- Enhanced Productivity and Asset Utilization: Optimized process control coupled with high-cell-density culture significantly increases product yield per batch. Simultaneously, existing manufacturing facilities can be utilized more efficiently, leading to improved asset productivity and contributing to reduced manufacturing costs.
Background & Context
The global demand for biopharmaceuticals is rising, placing pressure on manufacturing companies to increase production capacity and reduce costs. Fed-batch culture is the most common approach for manufacturing biologics like antibodies, but there’s a continuous push to enhance its efficiency. The adoption of PAT is an industry-wide trend aimed at deepening process understanding and control, enabling more efficient and robust manufacturing processes.
Strategic Significance & Outlook
Lonza’s OptiALTO™ platform, leveraging Raman spectroscopy as PAT, will play a crucial role in enhancing the efficiency and sustainability of biopharmaceutical manufacturing. This technology is expected to shorten lead times and reduce manufacturing costs, particularly in the mass production of antibodies and other recombinant proteins, thereby facilitating broader patient access to innovative therapies. In the future, such integrated PAT strategies are anticipated to converge with digital twins and AI, driving further automation and optimization in biomanufacturing.
Source: https://www.lonza.com/integrated-biologics/manufacturing/optialto-intensified-fed-batch-platform
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