Cellular Origins, Resolution Therapeutics, and Cell and Gene Therapy Catapult (CGT Catapult) say they set up a project aimed at using novel technologies to deliver a hyper-efficient, fully automated, scalable cell therapy manufacturing platform. The project, which has been awarded a cross-industry Smart Grant of one million British pounds ($1.4 million) from Innovate UK, began on July 1 and will last 20 months.
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. They 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,” said Edwin Stone, CEO, Cellular Origins. “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.”
Full integration
The project plans to 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, according to officials at Cellular Origins.
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, noted Matthew Durdy, chief executive, CGT Catapult.
“One of the most challenging problems to international delivery of CGTs to patients continues to be manufacturing,” noted Durdy. “It is clear that robotics, AI, and digitization 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 is also expected to benefit from the input, advice, and direction of Resolution Therapeutics, which will provide corporate, clinical, and commercial expertise as a therapy developer of a new type of cell therapy called Regenerative Macrophage Therapy (RMT) with lead asset to treat end-stage liver disease.
“Our regenerative macrophage therapy program is now in the clinic,” said Amir Hefni, CEO of Resolution Therapeutics. “Our lead asset, RTX001, is currently in Phase I/II 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 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.”
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