CGT Catapult concludes the Process Analytical Technologies (PAT) consortium aimed at improving ATMP bioprocessing

CGT Catapult concludes the Process Analytical Technologies (PAT) consortium aimed at improving ATMP bioprocessing

CGT Catapult concludes the Process Analytical Technologies consortium which brought together 24 organisations to improve understanding of cell bioprocesses.

In 2021, the Cell and Gene Therapy Catapult formed a consortium of 24 organisations, with a shared goal to gain a better understanding of cell bioprocess and the sufficient control needed to develop ATMPs. From cells, sensors and analytical technologies, the respective organisations each brought together a variety of expertise to develop a system that can provide real-time monitoring and adjustment of cell bioprocess for better, faster and cheaper ATMP manufacture.

The project sought to generate – and delivered – real-time PAT datasets from two T cell bioprocess cycles for use by CGT Catapult and its partner organisations within the PAT consortium. This has helped to address the scientific uncertainty surrounding what is happening with these cells, and monitor their biological systems in real-time as they are modified into cell therapy medicine.

The consortium, which included pharmaceutical companies, technology providers, therapy developers and charities, assessed the application and combination of multiple process analytical technologies (PAT) within the cell and gene therapy industry – all of which will be key to providing monitoring and control during the manufacturing process, and in turn reduce batch failures and manufacturing costs, thereby underpinning accelerated progress towards commercialisation.

Consortium members collaboratively investigated multiple PAT applied to an exemplar T-cell process. A three-stage process underpinned the work of the consortium; establishing the test environment, using technologies in an impartial environment, then monitoring the process, applying sensors and building a solution. By creating impact through collaboration, interconnecting personnel and interrogating newly created datasets, the consortium demonstrated the potential of new PAT for cell and gene therapy manufacture.

The consortium has not only improved the industry’s understanding of ATMP bioprocessing methods, which are typically hard to characterise, but has also helped consortium members understand the next steps required for better process automation to advance cell therapies.

There is much mention of applying AI and Machine Learning to CGT [cell and gene therapy] manufacturing these days but you need full process data for this, which starts with the right sensor technologies. The PAT consortium showed us where this technology is today, how it might be applied and what is lacking. How we can employ in-line, at-line and offline techniques to better characterise processes and products and we’re currently digesting the wealth and riches of data the project produced. Our conclusions show that there is still much to do, that CGT manufacturing has specific needs and that after eighteen years of closing our processing systems, we now need better suited technologies to use within them.

Jason Jones, Ori Biotech – PAT consortium collaborator

Working with CGT Catapult through the project has been resoundingly positive and valuable. They have well-orchestrated the convergence of highly diverse industry contributors and in the context of their outstanding expertise and resources. The external feedback on the use of our technology has guided us in making it more user-friendly and accessible. The expert feedback on the value of our solutions has also been greatly appreciated, helping to solidify our position in and view of the industry. Overall, we are grateful to have had the opportunity to work together and look forward to continuing our collaboration in the future. We see the project to have been a great contribution to the progression of the industry.

Ollie Harriman, See-Through – PAT consortium collaborator

This was a hugely significant piece of work for our sector, and the ability to attract and interconnect a whole range of organisations, large and small, is a remarkable achievement in itself. We all recognise that the ability to deliver ATMPs to patients on a widescale is hampered by a lack of these process analytical technologies and the delivery of new data around this area is critical to ensure that as many patients as possible benefit from breakthrough innovation in the space.

Matthew Durdy, Chief Executive at the Cell and Gene Therapy Catapult