Capacity, AI Driving Single-use Bioprocess Probe And Sensor Uptake

By Pankaj Singh, Global Market Insights

In the global biopharmaceutical landscape, single-use bioprocessing probes and sensors are emerging as pivotal components with a critical role in enhancing the efficiency and reliability of bioprocessing workflows. These devices address the burgeoning demand for more agile and contamination-free manufacturing of biologics and vaccines.

These devices are integral for real-time monitoring and controlling critical process parameters such as pH, temperature, oxygen levels, and conductivity, ensuring product consistency, quality, and compliance with regulatory standards. Single-use technologies have garnered significant attention in recent years, representing a paradigm shift in the production of therapeutics.

Pre-sterilized disposable components, ranging from bioreactors to tubing and connectors, have reduced the need for time-intensive cleaning validations and sterilization procedures characteristic of multiuse systems. Disposable systems inherently prevent the likelihood of residues from previous batches affecting subsequent production cycles, thereby enhancing product safety and quality.

Deploying single-use probes and sensors in bioprocessing applications offers advantages over traditional reusable counterparts, including minimizing cross-contamination risks, reducing setup times, and eliminating complex cleaning processes. As biopharmaceutical companies increasingly lean toward single-use technologies, the development of advanced environmentally responsible probes and sensors will remain instrumental in shaping the future of bioprocessing.

According to a Global Market Insights Inc. (GMI) report, the single-use bioprocessing probes and sensors industry’s value will surpass $10 billion by 2032 as compared to $3 billion in 2023, with rising adoption in upstream and downstream workflows. As the biopharma field continues to evolve, stakeholders must remain aware of the opportunities and responsibilities accompanying the widespread implementation of single-use systems.

Accelerated Investments In Capacity Expansion

The biopharmaceutical sector is witnessing a significant influx of investments to augment production capacity. This strategic allocation of capital is driven by the need to innovate and expedite the delivery of critical therapeutics. With the industry gravitating toward more flexible, scalable, and contamination-free environments, the dependence on disposable technologies becomes more pronounced.

Leading players in the biopharma domain have affirmed this rapid expansion through undertakings across different regions over the past couple of years. For instance:

• In the U.S., Bayer AG announced a significant investment of $250 million to open a new cell therapy manufacturing facility in Berkeley, California. The state-of-the-art facility will support the production of clinical trial materials and potentially the commercial launch of a cell therapy under investigation for Parkinson’s disease treatment.
• In Europe, Novo Nordisk confirmed a large expansion plan for its manufacturing capabilities in Denmark, worth over $6 billion. A considerable portion of the funds is designated specifically toward expanding API capacity, highlighting the crucial role single-use probes and sensors play in drug development and production.
• Through a $325 million project, Merck is set to establish a new bioprocessing production center in Daejeon City, South Korea, expanding its life sciences business sector into APAC with its largest investment in the region. In February 2024, Thermo Fisher Scientific commissioned a new sterile drug manufacturing facility in Singapore, positioning the city-state as a rising biomedical nexus in APAC.

The significant investments undertaken to build new facilities and expand production capacities certainly emphasize the potential demand for single-use technologies. To develop cell therapies for disorders such as Parkinson’s disease, single-use bioprocessing probes and sensors ensure a controlled and sterile environment, which is crucial for cultivating dopaminergic neurons and other cell types intended to restore neural function. These components are also critical to ensure better process control, regulatory compliance, and operational efficiency and to maintain high quality standards.

Integration Of AI In Biopharma

The biopharmaceutical and bioprocessing industries are experiencing unprecedented growth, fueled by a confluence of technological innovation, regulatory support, and heightened investment activity. The integration of capabilities like artificial intelligence (AI) and machine learning ensures a competitive edge through:

• Enhanced Control of Bioprocessing Operations: The application of cutting-edge analytics provides access to rapid, precise insights, ensuring a more informed and agile approach to process management.
• Gradual Rise of Bioproduct Quality: Superior data analysis translates into refined decision-making capabilities, culminating in better process control and effective mitigation of risks to enhance the quality of bioproducts.
• Optimized Production Scheduling: The synergy of faster and improved knowledge management facilitates improved production planning. This capability enables immediate cessation of suboptimal batches, streamlining the overall production timeline.
• Boosted Production Capabilities: The strategic adoption of smart process development, fine-tuned through AI and ML, allows for an expansion of production capacities, meeting the growing demands with greater efficacy.
• Augmented Production Efficiency: By harnessing predictive analytics and advanced process development, bioprocessing units can achieve high-throughput manufacturing. This approach notably curtails waste while amplifying yield.

As industry frontrunners and investors pilot these innovations, the potential for scaling operations, enhancing product quality, and optimizing resource utilization will deliver new benchmarks for excellence in bioprocessing.

Biopharma AI Innovation Demands Flexibility

GMI reports that biopharma and pharmaceutical end users will hold a greater than 36% share of the global single-use bioprocessing probes and sensors industry during 2024.

Bioprocessing in Europe and North America is advancing through high-tech maturation and integration of Industry 4.0 technologies, such as AI and IoT, enhancing analytical capabilities and process control. There is a significant opportunity for biopharma professionals to adopt AI-driven tools and models to meet the increasing demand for sophisticated production capabilities. Integrating AI within bioprocessing workflows can greatly enhance predictive analytics, process optimization, and quality control, thereby ensuring superior scalability and product consistency in response to evolving markets.

In May 2024, Accenture confirmed an investment in Turbine, a predictive simulation company, to enhance biopharma research with AI-powered cell simulations. The deal is aimed at uncovering vital biological insights, streamlining drug target identification, and expediting the development of targeted treatments. Single-use technologies provide the agility to swiftly adjust production volumes in response to fluctuating demands. This flexibility proves advantageous in AI-driven biopharma processes, which frequently necessitate rapid prototyping and iteration.

Through predictive analytics and machine learning, AI enhances the control and automation of bioreactors, ensuring optimal environmental conditions are consistently maintained. Such capabilities will not only streamline the production process but also facilitate the scalability and sustainability of operations.

Another recent development revealed that Pfizer utilizes AI and machine learning to monitor mammalian cell culture bioreactors in near real time, via the Manufacturing Intelligence Edge (MI Edge) platform created using AWS. This indicates a trend toward integrating more sophisticated digital technologies into bioprocessing, which, in turn, will drive the demand for compatible advanced single-use sensors.

Conclusion

As the biopharmaceutical sector continues to evolve and innovate, the demand for advanced bioprocessing solutions will only intensify. Booming demand for personalized and targeted therapies, such as cell and gene therapies, is expected to drive the adoption of single-use bioprocessing probes and sensors. These cutting-edge therapies often involve complex and sensitive bioprocessing steps, requiring precise monitoring and control to ensure product safety and efficacy.

Single-use probes and bioprocessing sensors are critical in upstream and downstream processes for the control of bioreactors, offering quick insights into cell culture conditions, ensuring optimal cellular productivity, and monitoring of purification and separation processes. Rigorous parameters such as pH, dissolved oxygen levels, and nutrient concentrations are managed with precision, directly influencing the critical quality attributes of the biologic under development.

The development of novel sensor technologies, such as optical and electrochemical sensors, will enable more accurate and reliable monitoring of critical process parameters. A fundamental need for advanced monitoring and control systems becomes paramount to ensure consistent product quality and regulatory compliance. The inherent flexibility of single-use systems empowers biomanufacturers to rapidly adapt to changing product demands and process requirements, promising a robust outlook for probe and sensor manufacturers over the coming years.

About The Author:

Pankaj Singh is a writer at Global Market Insights who writes about business, technology, trade, and finance.