Cytiva and Cellular Origins have partnered to advance the cell and gene therapy manufacturing process.
By combining Cellular Origins' automated robotic platform Constellation with Cytiva's automated Sefia platform, the companies hope to simplify the scale-up of CGT production.
According to the two, their platforms can enable CGT developers to scale-up their production to industrial levels without changing the processes used during the discovery and clinical trial phases.
Meeting CGT production needs
Currently, under half of the patients referred to receive CAR-T therapies get access to it.
Since CAR-T therapies are personalised and require significant manual labour to produce, they are are often complex to manufacture.
There is also a significant risk of batch failure when cultivating CAR-T cells, making it more challenging for drug developers to get these therapies to patients who need them.
Cellular Origins and Cytiva believe that a modular robotic approach could help manufacturers scale their processes to allow the production of hundreds of thousands of CGT doses per year.
By integrating their two systems, the pair hope to allow their customers to manufacture commercialised and late-stage CGT products without redesign.
Through automation, the technologies can also expedite the manufacturing process, allowing batches to be distributed to patients quicker.
This exclusive work is underway, and the first systems are set for process and biological testing in early 2025. GMP systems are expected to be available by the end of 2025 for clinical use.
Edwin Stone, CEO, Cellular Origins, commented: “The manufacturing of cell and gene therapies must evolve from personalised and small batch medicine to industrialisation if these therapies are to reach their potential for patients. At Cellular Origins, we are working
to make this a reality. By collaborating with Cytiva, a leading life sciences provider, we are building a unified automation platform that can meet the sector's large-scale industrial needs.”
Emmanuel Abate, President Genomic Medicine, Cytiva, added: “Countless patients have benefited from Cytiva's cell processing systems, and we remain enthusiastic about the therapeutic potential of CAR-T. We firmly believe that automating these processes will unlock
wider access to these life-changing therapies."
"The open nature of Cellular Origins’ design fits seamlessly with Cytiva's Sefia platform and potentially benefits a wide array of therapeutic developers. We are excited to see what the combined potential of our collaboration brings to the future of medicine.”