Cellular Origins, a TTP Company, focused on enabling scalable, cost-effective, and efficient manufacture of cell and gene therapies (CGTs), has announced an international collaboration with Thermo Fisher Scientific.
JHVEPhoto Shutterstock
The collaboration will combine Thermo Fisher’s proven cell culture and processing technology and Cellular Origins’ CGT robotic manufacturing platform, Constellation, to deliver full, robotic, 24/7 production of CGTs to the advanced therapy sector at the industrial scale. Both companies aim to achieve the largest production output of CGTs per square metre of manufacturing space, as well as the lowest labour requirements currently available within a digitally integrated framework.
The primary aim of the teamwork will be to support scaling up late-stage trials and commercial production, where automated robotic manufacturing solutions are most needed. They will work towards optimising the best use and layout of hardware in a facility at the most efficient unit operation ratios and for the greatest degree of output, with the smallest degree of risk.
Initially, the two companies completed the integration work on the physical adaption of Thermo Fisher products to Cellular Origins’ robotic platform. Integration of software into the digital layer has also been completed, which is essential for the combined solution to operate effectively.
The first customer installation of a robotically operated Constellation platform with the integration of Thermo Scientific Heracell VIOS AxD CO2 incubator technology has now been completed at the Digital and Automation Testbeds in the Cell and Gene Therapy Catapult’s Stevenage Manufacturing Innovation Centre, Stevenage, UK. Extensive validation and testing will follow.
“Cellular Origins can now greatly exceed the efficiency of manufacturing space utilisation and so production outputs per square metre of any system currently used to produce cell therapies whilst allowing for manufacturing in a low-grade background (Grade C/D),” said Edwin Stone, CEO, Cellular Origins. “We are signing key, long-term partnerships with the most important providers across the CGT sector. Our relationship with Thermo Fisher Scientific will be vital. Together, we will be able to deliver the largest output of CGTs per square metre and lowest labour requirements. Cellular Origins is collaborating with leading companies across the sector to achieve the delivery of affordable CGTs to patients. The sector needs to increase output from thousands of doses to multiple tens of thousands in less than 24-36 months, and then hundreds of thousands of doses soon after. Industrialisation, and automated robotics will be the only way to achieve this in a way that societies can afford.”
The modularity and configurability of Constellation allows unit operation densities to be specifically increased for those that require it most, including an unlimited increase in high throughput cell culture capability to scale up CGT production. When used jointly with the VIOS AxD CO2 Incubator, the starting material receives the utmost level of protection throughout culturing. The advancements delivered by Cellular Origins’ technology, including a more than 51% increased utilisation of manufacturing space and a 16-fold reduction in labour requirements will reduce the overall cost of goods of CGTs by over 51%.
“CGT manufacturing is evolving at a historic pace to catch up with therapeutic development, as well as to serve the rollout of the number of imminent therapeutic approvals for wide-spread indications,” said Douglas Wernerspach, sr. business director/general manager - CO2 Incubators and Biological Safety Cabinets, Thermo Fisher Scientific. “Increasing automation manufacturing and throughput and reduced need for human labour will be essential for the CGT sector to continue to advance. As a result, we are working with Cellular Origins to provide a full industrialised manufacturing service to the sector. Our VIOS AxD CO2 incubator is designed for just such a system.”