Cellular Origins, a TTP Company focused on enabling scalable, cost-effective and efficient manufacture of cell and gene therapies (CGTs), and the Cell and Gene Therapy Catapult (CGT Catapult), an independent innovation and technology organisation specialising in the advancement of the cell and gene therapy industry, has begun collaborations to demonstrate the benefits of automation in 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.
CGTs continue to increase in prevalence
A total of seven CGT therapies received FDA approval in 2023 —a number predicted to rise even further in 20241. In addition, increasing recommendations from regulators for CGTs to be used as earlier line treatments2 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.
Digitalising the CGT manufacturing process
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.
Constellation fluidically and digitally integrates existing bioprocessing equipment, with minimal change to both the biological process and the bioprocessing equipment
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, commented: “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.”