New powerhouse created to advance Cell and Gene Therapy automation
Working together on the project are Cambridge's Cellular Origins, a TTP company focused on enabling scalable, cost-effective and efficient manufacture of cell and gene therapies, and the Cell and Gene Therapy Catapult – a Stevenage-based independent innovation and technology organisation specialising in the advancement of the cell and gene therapy industry.
Their collaboration is designed to demonstrate universal automation of CGT manufacturing.
The partnership will undertake the physical and digital integration of existing bioprocessing equipment at the CGT Catapult’s Stevenage Manufacturing Innovation Centre (MIC) using Cellular Origins’ robotic platform, Constellation™.
By bringing together CGT Catapult’s expertise in GMP operations and optimisation with Cellular Origins’ Constellation, the goal will be to evidence the benefits of automation in real world applications and advance the fields’ understanding of how automation can impact the barriers to scale that have held progress back.
2023 was a landmark year for the CGT industry, further demonstrating the growing need to scale CGT manufacturing. Seven therapies received FDA approval - a number predicted to rise even further through 2024.
Also, increasing recommendations from regulators for CGTs to be used as earlier line treatments will likely see the sector transition from treating thousands to up to 10’s or 100’s of thousands of patients in the coming years.
Despite the anticipated surge in demand, a lack of capabilities to efficiently manufacture these therapies at scale has led to a widening divide between the number of doses produced and the number of patients that could benefit from them.
The unique benefit of Constellation is universal automation that fluidically and digitally integrates a wide range of existing bioprocessing equipment, with minimal change to both the biological process and the bioprocessing equipment. Constellation’s use of automated tube welding allows it to adapt to the process, consumables, and equipment, rather than the other way round and without the need to add new components or connectors.
This enables therapy developers to scale their CGT therapy and treat greater patient numbers without the delays and risk of having to re-develop their manufacturing process.
Constellation will be based at the CGT Catapult’s Stevenage MIC in its digital and automation testbeds, a newly developed pre-Good Manufacturing Practice (GMP) space for collaborators to develop digital and automated solutions to challenges that arise in the manufacturing of advanced therapies.
The Stevenage MIC is a GMP-compliant facility licensed for clinical and commercial ATMP production, focused on developing manufacturing processes at scale, speed, and according to GMP.
Dr Edwin Stone, CEO at Cellular Origins, said: “The CGT Catapult is a world-leading specialist in the field of cell and gene therapy, and we are delighted to announce this collaboration, enabling us to access their expertise and leverage the full potential of Constellation to revolutionise CGT manufacturing at scale.
"CGT Catapult’s experience in establishing GMP facilities and optimising cell therapy manufacture is directly aligned with Cellular Origins’ mission to prove the impact automated manufacturing can have in transforming cell therapy production.
"Through this partnership, we will work to demonstrate an automated manufacturing approach that will provide a route for patients worldwide to access these life-saving therapies.”
Matthew Durdy, Chief Executive at the CGT Catapult, added: “Embracing automation is a key step that the cell and gene therapy industry must take to reduce costs, increase efficiency and meet the growing demand for advanced therapies.
“Through working with leading robotics and software experts such as Cellular Origins, we aim to develop new strategies that increase levels of automation. This will help our collaborators access the benefits of these technologies, help make advanced therapies more affordable to healthcare systems, and help more patients receive life changing therapies.”