The Advanced Therapies Europe 2024 conference in Estoril, Portugal, set the stage for crucial discussions about the future of cell and gene therapy (CGT) manufacturing. As the industry stands on the brink of scaling these innovative therapies to meet growing patient demand, the message was clear—automation and digitalisation are key to unlocking the next phase of growth.
This need was recognised at the event, with a major focus around how to bridge the gap between today's manufacturing practices and the future vision of fully automated, digitally integrated processes. The conversations centred on simplifying processes to ensure scalability and affordability, while maintaining high quality.
As an attendee and speaker at Advanced Therapies Europe 2024, Dan Gibson, Head of Collaborations at the Cell and Gene Therapy Catapult, provides an overview of his takeaways from the event.
Streamlining cell and gene therapy processes
The first session that involved the Cell and Gene Therapy Catapult was hosted by ScaleReady, where conversations emphasised the importance of simplicity in CGT process design and how overcomplication can become a major roadblock when trying to scale.
As these therapies move towards wider adoption, cost-effectiveness becomes critical and keeping processes simple helps ensure scaling remains feasible. Streamlined processes are vital for efficient scale-up, especially in the heavily regulated world of CGTs, where every step is scrutinised. The call for simplicity wasn’t just about making things easier—it’s about ensuring that scaling CGTs remains both achievable and economically viable.
Towards automation and digitalisation
CGT Catapult’s workshop titled ‘‘Bridging the Gap: Next-Generation Manufacturing Strategies for Cell and Gene Therapy’, brought together key players from across the advanced therapies sector. The workshop explored the steps the sector must take to close the gap between current CGT manufacturing and the vision of fully automated, digitally connected operations.
Automation and digitalisation were highlighted as key to achieving the scalability needed to meet future patient demand and truly embed industry 4.0 principles into our sector. It’s about integrating automation across the entire value chain, from development through to commercialisation.
Technologies like robotics, Process Analytical Technologies (PAT), and digital twins were identified as essential in this transformation, and whilst the timing of integrating these technologies must be balanced to ensure we don’t over burden early process development or escalate costs unnecessarily, it is important to define the strategy and produce a robust development road map.
During the workshop, Rhys Macown, Lead Process Development scientist at the CGT Catapult, highlighted the unique challenges facing the CGT sector. Unlike other industries that have evolved over time, CGT manufacturing needs to make a leap into Industry 4.0 in one go.
One intriguing idea came from Jason Jones, Global Business Development Lead, at Cellular Origins, who introduced the concept of "switching gears, not processes." Rather than reinventing the wheel, he advocated for enhancing existing systems through automation. His approach keeps the successful platforms used in preclinical and early clinical stages intact, while adding advanced robotics to fill gaps in the process.
This strategy of wrapping automation around established processes ensures greater efficiency and scalability, without disrupting the workflow. It was a refreshing, practical perspective that resonated with many attendees who are navigating the complex balance between innovation and maintaining the quality of their therapies.
Amol Ketkar, Chief Development Officer at Resolution Therapeutics, offered a developer’s perspective to the workshop and acknowledged the tension between proving efficacy and planning for scale.
Many developers are focused on getting therapies through clinical trials, with scalability sometimes being an afterthought. However, Amol urged developers to engage with automation specialists early, as this can help prevent bottlenecks when it's time to scale up.
He also stressed the importance of automating Quality Control (QC) processes, given the inherent variability in human-sourced materials. Amol explained that automating QC isn’t just about meeting regulatory standards; it’s about managing variability and ensuring consistent product quality.
This was a thought-provoking idea because consistent product quality is not just a goal to be achieved but also a confidence we need to have as therapy developers when giving our products to patients as a chance to save or improve their lives. The more we know about our products now will ensure we can be confident that they are scaled appropriately.
Unlike traditional industries where failure rates are low, CGTs are still in the early stages of scaling and face significant variability challenges. As the sector grows, it will need to address both the biological and process variability that arises during large-scale production.
The reality is we have not yet operated at a level where we have unearthed detailed information on what contributes to process failures. Other industries, such as automotive and electronics, have overcome similar challenges and implemented solutions for low frequency failure rates. Learning from these long-established industries could help the CGT sector avoid the pitfalls of scaling too quickly without a robust plan for managing variability and the contributors to process failures.
Collaboration is key
A major theme running through Advanced Therapies Integrates 2024 was the necessity of collaboration. No single company or organisation can solve the challenges of CGT manufacturing on its own. The complexity of scaling living therapies, coupled with the need for regulatory compliance and cost control, means that partnerships are essential.
Cross-industry collaboration between therapy developers, automation specialists, regulators, and adjacent sectors will be key to building the infrastructure needed to bring CGTs to the masses. The consensus was clear: working together is the only way the industry can meet the growing demand for these life-changing therapies.
Contact us today to learn more about how we can collaborate and support you to overcome your cell and gene therapy development challenges
What’s next?
At the CGT Catapult, we are committed to growing our digital and automation testbeds and expanding the capabilities of these. These pre-Good Manufacturing Practice (GMP) modules are among the world’s first sandbox environments to provide CGT developers with access to cutting-edge automation, digital and robotics solutions with the aim to reduce manufacturing costs and enable more patients to be treated.
As the industry evolves, we recognise the critical need for advanced, sustainable manufacturing practices. Our upcoming plans focus on both scaling these testbeds and ensuring they are tailored to meet the most pressing needs of the CGT sector. By continually improving and refining these environments, we aim to accelerate the development of efficient, scalable processes for CGTs.
A key aspect of this expansion involves addressing the broader challenge of sustainability in medicines manufacturing. As the demand for advanced therapies grows, so too does the potential environmental impact if we fail to act now.
We are exploring ways to improve process efficiency, integrating circularity principles into manufacturing, and advancing sustainable practices. This means focusing on waste reduction, energy efficiency, and material reuse, all while maintaining stringent product quality standards. If we do not make sustainability a priority, the rapid scale-up of these therapies could contribute to significant environmental consequences.
By working proactively, we believe that process improvement is not just a necessity, but an opportunity to lead the way in sustainable manufacturing. We are committed to partnering with industry leaders and innovators to drive these efforts forward.
If you're interested in exploring how our digital and automation testbeds can support your development, or if you’d like to learn more about collaborative opportunities, please contact us . We are always looking for new partners to help shape the future of sustainable, efficient manufacturing in cell and gene therapies.