Cytiva Collaborates with Cellular Origins to Deliver Automated Manufacturing for CGTs

Editor's note: this story was originally published on BioPharmInternational.com.

Cytiva and Cellular Origins, a TTP company based in the UK that specializes in advancing scalable and cost-effective cell and gene therapy (CGT) manufacturing, have partnered to combine technology platforms that will offer automated, robotic manufacturing of CGTs, Cytiva announced on Jan. 16, 2025. Under the agreement, Cytiva will combine its automated Sefia platform with Cellular Origin’s Constellation, an automated robotic platform. The integration of these two technologies aims to enable scale-up of CGT manufacturing to industrial levels without changing the initial manufacturing process used during discovery phases or clinical trials, according to a company press release (1).

The two systems are expected to have a seamless interface, which will provide complete digital interconnection. This interconnection will encompass quality control systems, fully remote digital controls, and analytics. The integration will remove the need for manual intervention between and within CGT manufacturing steps. The companies expect that the combined technologies will help drive new standards of automation and manufacturing productivities.

“The manufacturing of cell and gene therapies must evolve from personalized and small batch medicine to industrialization 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 … we are building a unified automation platform that can meet the sector's large-scale industrial needs,” said Edwin Stone, CEO, Cellular Origins, in the press release (1).

Work is already underway to integrate the platform technologies, and the first systems are set for process and biological testing in early 2025. Good manufacturing practice systems are expected to be available by the end of 2025 for clinical use.

The companies estimate that 47% of referred patients currently get access to chimeric antigen receptor T cell (CAR-T) therapies (2). Current manufacturing practices for CAR-T therapies heavily rely on manual labor, which adds to the complexity and variability of its production process. Meanwhile, limited manufacturing capacity, significant risk of batch failures, and the expected increase of regulatory approvals for wider indications are expected to present more challenges for drug developers to satisfy the growing patient demand.

“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,” said Emmanuel Abate, president Genomic Medicine, Cytiva, in the release.

The companies realize that a modular robotic approach will help manufacturers scale up from thousands to hundreds of thousands of CGT doses per year, according to the press release. With the integration of the two technology platforms into existing customer workflows, those workflows will be enabled to manufacture commercially approved and late-stage CGT products around the clock without the need to change systems or redesign approved processes.

References

1. Cytiva. Cellular Origins and Cytiva are Collaborating to Deliver Automated Robotic Manufacturing Capabilities for Cell and Gene Therapies. Press Release. Jan. 16, 2025.
2. IQVIA. Strengthening Pathways for Cell and Gene Therapies: Current State and Future Scenarios. Market Research Report, iqvia.com. March 13, 2024.