Cellular Origins, the Cell and Gene Therapy Catapult (CGT Catapult), and Resolution Therapeutics, have formed a consortium.
The project aims to use novel technologies to deliver, for the first time internationally, a unique, hyper-efficient, fully automated, scalable cell therapy manufacturing platform. The project will last for 20 months. The consortium has been awarded a cross-industry Smart Grant of £1m from Innovate UK, UK’s national innovation agency.
The consortium partners have chosen to collaborate by combining their respective expertise in robotic and digital technologies, manufacturing processes, operations and facilities management, therapy development, novel product processes, and patient delivery. The partners intend to expand this collaboration further through future joint development and delivery capabilities. Providing additional support to the project are ScaleReady with its G-Rex bioreactor platform, and Autolomous with its AutoloMATE eBMR solution.
“Despite the incredible therapeutic performance of cell therapies, therapy development has greatly outpaced the ability for these treatments to be manufactured in sufficient quantities to reach all eligible patients. Manual manufacturing has only been able to be scaled up to deliver a few thousand patient doses per year. The CGT sector is currently only capable of manufacturing sufficient doses to treat less than 7% of eligible patients globally,” said Edwin Stone, CEO, Cellular Origins.
“To deliver therapies to the patients that need them requires fully automated manufacturing of the type that has revolutionised other high-tech manufacturing. This requires solving the cell therapy specific technology challenges that allow the adoption of advanced robotics and AI into cell therapy manufacturing. This partnership with the CGT Catapult and Resolution Therapeutics, and the funding by Innovate UK, will deliver the most advanced, fully tested, fully automated robotically operated CGT manufacturing platform to the market. Cellular Origins’ already established network of partnerships, most recently added to with our collaborations with Cytiva, Fresenius Kabi, Thermo Fisher Scientific and Johnson & Johnson, gives this specific consortium access to proven robotically automated manufacturing technology.”
The project will deliver full integration of the hardware and software of Constellation, Cellular Origins’ CGT robotic manufacturing platform, at the CGT Catapult’s Digital and Automation Testbeds in the Stevenage Manufacturing Innovation Centre, UK. These testbeds serve as good manufacturing practice (GMP)-mirroring sandbox environments for de-risked and accelerated testing and adoption of next-generation technologies. CGT Catapult will commission the platform within the real-world manufacturing environment of its testbeds to support the national and international roll-out of Constellation. This world-first installation will be fully accessible to collaborators through the Digital and Automation Testbeds.
“CGTs continue to deliver unparallelled therapeutic efficacy and life-saving or transforming options for a plethora of patients with currently limited therapeutic options. There is an opportunity for the UK to lead innovation in this sector, and ensure patients have access to the therapies they need,” said Matthew Durdy, chief executive, CGT Catapult.
“One of the most challenging problems to international delivery of these therapies to patients continues to be manufacturing. It is clear that robotics, AI and digitisation have now advanced to provide the required solution. The combination of three UK leaders in their respective CGT sectors will result in the reduction of costs and increase in manufacturing efficiency and capacity required to bring transformative therapies to patients. The funding by Innovate UK will give further support to ensure the UK remains at the forefront of CGT development.”
The project will also benefit from the input, advice and direction of Resolution Therapeutics. Resolution will provide corporate, clinical and commercial expertise as a therapy developer of a promising and exciting new type of cell therapy called regenerative macrophage therapy (RMT) with lead asset to treat end-stage liver disease. Resolution will inform the development direction and viability to ensure the adaptability of the platform for novel cell therapies such as for Resolution’s groundbreaking macrophage therapy products. This will result in the route map and the transformation from manual clinical-scale manufacturing to fully automate, GMP-ready, commercial-scale CGT manufacturing at the scale required to meet areas of significant unmet need.
“The field of cell and gene therapy (CGT) continues to expand, delivering an increasing range of innovative platforms with the potential to transform patient outcomes – such as our Regenerative Macrophage Therapy (RMT) platform,” said Amir Hefni, CEO of Resolution Therapeutics.
“Our regenerative macrophage therapy program is now in the clinic. Our lead asset, RTX001, is currently in phase 1/2 studies for the treatment of end-stage liver disease, with additional programs in development for a number of inflammatory and fibrotic diseases, including graft-versus-host disease and lung fibrosis. We are also collaborating with the CGT Catapult and Cellular Origins to leverage advanced automated robotics technology. This partnership will enable the scalable and cost-efficient manufacturing of next-generation CGTs, ensuring greater patient access to our therapies.”
Cellular Origins has already completed pre-activity for the project by installing the first Constellation system at the CGT Catapult’s Digital and Automation Testbeds in Stevenage. The intention is for full market supply and application of the automated robotics manufacturing platform for CGT developers, integrating known and proven instrumentation from trusted third-party suppliers with minimum process change, within Cellular Origins’ workstations and factory installations.
Jim Cornall is editor of Deeptech Digest and publisher at Ayr Coastal Media. He is an award-winning writer, editor, photographer, broadcaster, designer and author. Contact Jim here.
