Continuous bioprocessing refers to a method of biological manufacturing where inputs such as cell culture media, oxygen and other nutrients are continuously fed into the bioreactor system while outputs like harvested cells, therapeutic proteins, and waste are simultaneously removed. This contrasts with traditional batch manufacturing where inputs are added at the start of the process and products are harvested at the end of a fixed time period.
Advantages Of Continuous Operation
Continuous operation offers several advantages over batch methods. Firstly, it improves productivity by allowing non-stop operation and harvesting. This means facilities can operate 24/7 without downtime between batches for cleaning and preparation. Continuous bioprocessing also supports a higher annual capacity from a single piece of equipment.
Secondly, continuous processes allow tighter control over culture conditions like pH, temperature and nutrient levels. Operational parameters can be more precisely monitored and adjusted in real-time to keep the cells in their optimal growth environment. This consistency in operating conditions batch-to-batch improves process reproducibility.
Thirdly, continuous processes are often more sustainable. The continuous removal of waste products prevents their build up in the bioreactor which could inhibit cell growth. It also uses growth medium and energy resources more efficiently with constant-fed, constant-harvest operation and no downtime between batches.
Implementation Challenges
While continuous operation confers clear benefits, transitioning existing batch processes to continuous mode is not straightforward. Firstly, extensive process development work and characterization is required to understand cell behavior under continuous conditions. Cell lines may need re-engineering to maintain viability and productivity in a continuous flowing environment.
Secondly, continuous bioprocesses require more sophisticated control systems to monitor multiple in-process parameters and regulate inputs and outputs on a continuous basis. Control at this level of complexity is challenging.
Thirdly, equipment design needs to support plug flow hydrodynamics with no dead zones, to prevent cell settling and ensure uniform conditions throughout the bioreactor. Novel bioreactor configurations have been developed but designing for continuous operation is more demanding than batch.
Lastly, continued production requires an uninterrupted supply of inputs like freshly prepared growth media. Ensuring reliability of upstream processes that supply the bioreactor is critical to maintaining continuous output.
Operational Challenges
Even after setting up the sophisticated infrastructure, continuous bioprocesses still face operational challenges. Maintaining stable cell viability and productivity over an extended operating campaign requires tight control of multiple parameters together. Any disturbances in one could lead to decline in others.
Secondly, as the process runs for weeks or months, minor changes in cell physiology are common as they adapt to the selective pressure inside the bioreactor. Such drift needs to be promptly detected and corrected.
Lastly, continuous removal of harvest also means continuous quality monitoring and assessment is needed to ensure final product meets all release criteria throughout the campaign. Unvarying product quality adds another layer of complexity to control.
Regulatory Considerations
Regulators also need to be convinced of the equivalence and consistency of continuously produced biotherapeutics compared to existing batch processed products. Extensive comparability studies will be required to qualify continuous processing as an alternative route. Regulatory reviews will need to address the different operational dynamic compared to batch and ensure all quality attributes are maintained regardless of the production mode. Finally, continuous processing may require different approaches for process validation due to its non-standard operating procedure. Overall regulator acceptance could be a long process.
Potential Of Continuous Processing
While implementation challenges remain, continuous bioprocessing's potential advantages are driving more pharmaceutical companies to invest in building this capability. As shortcomings in cell line design, bioprocess control and single-use equipment are addressed, feasibility will improve. Continuous processing allows multi-product facilities for a variety of drug substance. It can also support personalized medicines by facilitating small batch production. On the regulatory front, as more products gain approval via this route, confidence will rise. Overall, continuous bioprocessing's promise of higher efficiency, capacity and sustainability marks it as the future of biological manufacturing. With continued progress, it will increasingly become the production standard.
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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 )
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1. Source: Coherent Market Insights, Public sources, Desk research
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