A Key Talent and Expertise Required for Continuous Versus Batch BiomanufacturingA Key Talent and Expertise Required for Continuous Versus Batch Biomanufacturing

Transitioning from batch to continuous manufacturing requires scientists to overcome a number of obstacles. In continuous manufacturing, real-time process control is critical, requiring advanced-monitoring systems and automation to maintain consistency and product quality. Such systems can be difficult to implement, and they require frequent adjustments. Integrating upstream and downstream operations also must be seamless, requiring synchronization across fermentation and purification. Biologics are sensitive to environmental fluctuations, complicating product-quality management over long production periods.

Regulatory frameworks traditionally are built around batch processes. Continuous systems necessitate new approaches for validation, real-time release testing (RTRT), and compliance. Designing new facilities or retrofitting old ones makes for an expensive transition, especially when considering the complexity of ensuring supply-chain consistency. Handling failures is particularly challenging in continuous processes because disruptions can affect large product volumes, requiring sophisticated troubleshooting and recovery mechanisms.

Acquiring the Right Talent: Adopting continuous biomanufacturing requires specialized expertise and demands advanced knowledge of real-time process controls. The transition requires professionals who are skilled in automation, data analytics, troubleshooting, and process analytical technology (PAT) for real-time monitoring.

Expertise in integrated process design is critical because continuous biomanufacturing entails coordination between upstream and downstream operations. Talent skilled in predictive maintenance and advanced regulatory compliance is necessary, because continuous processes require shifting from batch-based validation to real-time release and compliance. However, biopharmaceutical companies are finding skills gaps in this field/area of expertise. Thus, they must retrain existing staff or hiring new talent with these advanced competencies.

In most cases, continuous biomanufacturing requires higher operation proficiency than batch biomanufacturing. For example, skills such as process control, automation expertise, and real-time data analysis are particularly crucial for continuous processes that require real-time adjustments and monitoring to maintain seamless production.

Talent and Expertise Requirements for Continuous Biomanufacturing: Continuous biomanufacturing requires operators who possess advanced skills in automation, monitoring, and control to maintain uninterrupted production. Key competencies include process-automation expertise with proficiency in programmable logic controllers (PLCs), distributed control systems (DCSs), and supervisory control and data acquisition (SCADA) systems along with experience using automation software. Skills in spectroscopy, in-line sensor calibration, and real-time data analysis using statistical process control (SPC) also ensure product consistency and process optimization.

Dynamic process control is another critical area of focus, requiring expertise in model predictive control (MPC) and advanced process control (APC). Companies also should have specialists in integrated system design to ensure seamless coordination between upstream and downstream operations and to maintain automated systems with predictive maintenance strategies. Real-time quality assurance is key, led by experts who have knowledge of RTRT and process validation in compliance with regulatory standards.

Top Five Skills Needed for Continuous Biomanufacturing

Real-Time Process Control: Real-time process control requires trained operators with tools such as PLC, DCS, and SCADA systems, which enable real-time monitoring and control of bioprocess parameters.

PAT Implementation: Companies should have workers who are proficient in using real-time near-infrared (NIR) spectroscopy and Raman spectroscopy to monitor critical parameters such as pH, temperature, and nutrient levels.

Advanced Automation and Equipment Integration: Operators need special expertise to integrate upstream and downstream processes into a continuous production line that requires minimal human intervention. For example, companies will need to coordinate bioreactor and filtration systems to feed downstream purification processes continuously.

Real-Time Data Analytics and Predictive Maintenance: Advanced skills in big-data analytics, machine-learning (ML) algorithms, and predictive maintenance systems are needed to anticipate equipment failures or deviations. For example, ML models can help predict maintenance requirements and avoid disruptions in continuous production.

Real-Time Troubleshooting: Continuous processing requires experts who can perform root-cause analyses to address and resolve process deviations and system failures before they affect large volumes of product.

Corresponding author Jason Beckwith, PhD, is managing director of Evolution Search Partners Ltd. in Glasgow, UK; [email protected]. Stephen Goldrick, PhD, is an associate professor in the Department of Bioprocess Engineering at University College London. William Nixon, PhD, is a emeritus professor, and Stavros Kourtzidis, PhD, is deputy associate dean of research, both in the Department of Business at the University of Dundee.