Pharmaceutical & medical SMALL BATCH,
BIG IMPACT EMBRACING FLEXIBLE MANUFACTURING FOR PERSONALISED MEDICINE
Pharmaceutical companies across the world are significantly increasing their investment in more personalised approaches to treatment. In fact, 42 per cent of all drugs currently in development are associated with personalised medicine. Here Stephen Hayes, managing director at automation and control specialist, Beckhoff UK, explains how flexible manufacturing systems, supported by advanced modular automation solutions, can meet the demands of personalised medicine.
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ersonalised medicine represents a shift from the one-size-fits-all approach to healthcare towards more individualised treatments. This change is driven by advances in genomics, biotechnology and data analytics, allowing treatments to be customised based on a patient’s genetic profile, lifestyle and specific disease characteristics. However, personalised medicine, which tailors treatments to individual patient profiles, demands an entirely different approach to production when compared to traditional mass production models. This creates new challenges for pharmaceutical manufacturers, as they must now be able to produce highly variable products in smaller batches while adhering to strict regulatory standards for quality and safety.
To successfully meet these demands, manufacturing systems need to be highly flexible, scalable and adaptable. Traditional production lines designed for mass manufacturing lack the necessary versatility to handle the complex and dynamic nature of personalised medicine. This is where flexible manufacturing systems come into play.
AGILE PRODUCTION
Flexible manufacturing systems are designed to handle variations in product design, batch size and production processes with minimal reconfiguration. They enable manufacturers to switch between different product lines rapidly, making them ideal for the personalised medicine sector where
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variability is the norm rather than the exception. Flexible manufacturing systems are characterised by their modularity, allowing different components of the system to be reconfigured or replaced as needed. This modular approach not only supports adaptability but also enhances scalability, enabling manufacturers to quickly expand production capacity in response to changing demands.
Key to the success of flexible manufacturing systems is automation. Advanced modular automation solutions, like those supplied by Beckhoff, offer the tools needed to optimise flexible manufacturing processes. These systems can handle complex, multi-step production processes, reduce human error and maintain compliance with regulatory standards.
REGULATORY COMPLIANCE Compliance with regulatory standards is non-negotiable in the pharmaceutical industry, especially with personalised medicine. Automated systems must not only ensure precision in manufacturing but also offer complete traceability, documentation and validation.
Automation can help support compliance and tracing by allowing for integrated data acquisition and real-time monitoring. For instance, TwinCAT from Beckhoff allows for continuous data recording and analysis throughout the production process, ensuring that all steps are fully documented and can be traced back if needed. This is essential for meeting
regulatory requirements and ensuring product quality. Beckhoff’s PC-based control systems also offer integrated support for Good Manufacturing Practices guidelines, which are crucial for maintaining the safety and efficacy of pharmaceutical products. By automating documentation and quality control tasks, these systems reduce the risk of human error and ensure that all products meet the necessary standards.
EFFICIENCY GAINS
The modular nature of automation systems means that manufacturers can easily scale their operations. Whether they are producing a small batch of customised treatments or ramping up production to meet increased demand, automation solutions provide the flexibility and efficiency needed to stay competitive in the rapidly evolving pharmaceutical industry.
PC-based control solutions offer fast communication and precise control, reducing downtime and improving overall equipment effectiveness (OEE). The real-time feedback
June 2025 Instrumentation Monthly
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