Transforming Cell and Gene Therapy Manufacturing: A People-Led Digital Revolution

A Case Study conducted with MFX

Case Study Authors

Dr James Kusena (MFX) and Dr Rebecca Grant (Loughborough University)

Context

Digital technologies have the potential to support the workforce with demanding job roles by enabling and enhancing human capabilities. Cell and Gene Therapy (CGT) manufacturing companies are heavily regulated to ensure patient safety, however the processes for manufacture and quality control are still quite manual and can place a physical and mental toll on the operator. By using digital technologies to identify where tasks become more challenging, companies can improve workflow design, reducing difficulty for operators, and ultimately minimise risk to the healthcare product.

Objective

The CGT industry is significant within the UK and globally, with the market set to grow, and more therapies being evaluated by agencies such as the UK’s MHRA.  Despite the life-changing potential of cell and gene therapies, they are complex and costly to manufacture. Significant progress is being made to move away from manual, repetitive processing, to more automated and data-driven growth and product release.  However, this transition presents challenges. More information for operators to consider and utilise can increase decision-making workloads and potentially overwhelm.

To address these challenges, we aimed to explore the integration of biometric technologies with traditional methods to identify difficult or stressful scenarios, and opportunities for process improvements and risk reduction.  In this study, MFX and the Centre for People-Led Digitalisation collaborated to identify how eye-tracking and workload analysis methods can be applied in CGT manufacturing.  The goal was to identify the challenges operators may face, and assess the impact of stress and workload, ultimately aiming to design processes that improve public health outcomes.

Approach

We used a laboratory-based process case study, with operators wearing eye-trackers to identify points of measured stress and task difficulty. The findings where then used in a workshop to pinpoint specific process areas that can cause variance, enhancing awareness through a cause-and-effect analysis. These areas of variance have lifted the lid on more people-led factors within CGT manufacturing, contributing to the industry's ongoing efforts to ensure that safety in manufacturing is effectively transferred to the patient.

Insight

From this study we were able to identify areas that cause increased variance within or between operators that could impact the process or product being manufactured. Consistent with similar studies of this nature, some of these people-based variances are common across industries, while others are unique to this healthcare setting.  This insight enables a more focused approach to process design and risk management. The study also demonstrated how to enhance processes such as Failure Mode & Effects Analysis, making them more comprehensive and specific to minimise  variabilities within human-centred systems.

Impact

“The application of digital technologies in this context underscores the potential for advanced data-driven methodologies to transform CGT manufacturing, making it more resilient and aligned with the growing demands of the healthcare industry. This collaborative work sets a precedent for how human factors can be systematically addressed in CGT manufacturing, paving the way for more efficient, safer, and scalable manufacturing practices in the future.

For MFX, the study has provided valuable insights into the design and process considerations that need to be taken. By integrating these insights into the broader context of Failure Mode & Effects Analysis, a more targeted strategy for mitigating variabilities within human-centred systems can be employed, ultimately enhancing process workflows, product reliability and patient safety. These considerations will help to ensure that the products and processes being developed are suitable and valuable to operators, ensuring improved technologies and workflows for CGT manufacturing.”

Dr James Kusena, Vice President of Operations & Product Owner, MFX

For further information on this case study please contact the PLD at P-LD@bath.ac.uk

Acknowledgement

The work reported in this paper was supported by the Made Smarter Innovation: Centre for People-Led Digitalisation, at the University of Bath, University of Nottingham, and Loughborough University. The project is funded by the Engineering and Physical Sciences Research Council (EPSRC) Grant EP/V062042/1.