Conventional batch bioprocessing has long been the standard approach for manufacturing biologics such as monoclonal antibodies, vaccines, and therapeutic proteins. However, batch manufacturing comes with certain limitations such as transient operation and thus results in inconsistent quality, lower product yields and increased costs for development and operations. Continuous bioprocessing presents an opportunity to address many of these limitations through its flow-through design.
In continuous bioprocessing, inoculated cell culture media continuously flows through a series of interconnected, aseptically controlled bioreactors and downstream processing units. Similar to other flow processes used widely in the chemical and petrochemical industries, continuous bioprocessing allows for continuous inoculation of fresh media, gradual harvest of product and simultaneous ongoing production, purification and processing. This enables seamless transition between different phases of the process and uninterrupted biomanufacturing.
Benefits Of Continuous Bioprocessing
Some of the key benefits of continuous bioprocessing over batch processing include:
Improved Production Capacity: With continuous harvesting and no downtime between batches, continuous systems offer significantly higher annual production capacity within the same facility footprint. This allows companies to scale production easily to meet demand.
Enhanced Process Understanding: Online monitoring in continuous systems provides a wealth of real-time data that improves understanding of cellular behavior and quality attributes. This facilitates rapid development and scale-up of robust manufacturing processes.
Increased Consistency: Constant environmental conditions maintained through precise control of multiple interconnected units ensure consistent product quality, attributes and performance across all outputs. This consistency reduces the need for interim testing and characterization.
Lower process-related risks: Challenges from variability between individual batches are minimized. The transient shocks to cells from batch changes are replaced with steady-state cell culture and gradual adjustments reduce process-related risks.
Superior Economics: Higher asset utilization, minimal batch failure and changeover losses, and the ability to incrementally increase capacity yield significant economic benefits. Continuous bioprocessing is estimated to offer 50-70% reduction in overall manufacturing costs.
Challenges And Solutions
Despite the compelling advantages, continuous biomanufacturing is still in a nascent stage compared to batch processing which has been optimized over decades of industrial practices. Some challenges that must be addressed to facilitate widespread commercial adoption of continuous processing include:
Complex Process Design: Continuous bioprocessing requires integration of multiple unit operations that must function seamlessly and in synchronization for uninterrupted flow. This complexity poses engineering and control challenges. Standardized modular systems and process analytical tools are enhancing design capabilities.
Skillset Gap: New expertise spanning different engineering disciplines like controls engineering, separation sciences are required in addition to traditional bioprocessing skills. Companies are investing in re-skilling existing workforce and partnering with academic institutions to build multi-disciplinary skillsets.
Limited Commercial-scale Installations: Most current examples are at lab/pilot scale. Lack of commercial-scale demonstrations resulting from high capital investment is a barrier, though this is slowly changing with new facilities coming online.
Regulatory Hurdles: Unclear regulatory guidelines around changes in process parameter operation mode pose uncertainties. Regulatory agencies are engaging with to develop science/risk-based guidance to facilitate approval of advanced manufacturing processes.
Technology Maturation: While unit operations are available, their integration requires further advances. Continuous downstream processing in particular lags upstream development. Investments in platform technologies will accelerate adoption.
The Future Looks Bright
Despite the persisting challenges, continuous bioprocessing is gaining rapid momentum driven by its compelling advantages. Major biopharmaceutical companies are making large strategic commitments towards its implementation, recognizing the importance of this transformation. The upcoming decade will likely see the scaled-up deployment of integrated continuous manufacturing platforms across the biopharmaceutical value chain. With enabling technology advancements and supportive regulatory evolution, continuous bioprocessing is projected to become the predominant biomanufacturing paradigm by 2030, revolutionizing an long dependent on batch processing.
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Author Bio:
Alice Mutum is a seasoned senior content editor at Coherent Market Insights, leveraging extensive expertise gained from her previous role as a content writer. With seven years in content development, Alice masterfully employs SEO best practices and cutting-edge digital marketing strategies to craft high-ranking, impactful content. As an editor, she meticulously ensures flawless grammar and punctuation, precise data accuracy, and perfect alignment with audience needs in every research report. Alice's dedication to excellence and her strategic approach to content make her an invaluable asset in the world of market insights. (LinkedIn: www.linkedin.com/in/alice-mutum-3b247b137 )
*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
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