Cellular Origins and Fresenius Kabi, an operating company of Fresenius, announced today they have signed a development agreement that leverages each company’s expertise in cell and gene therapies (CGTs). The agreement is designed with the goal of digitally and physically integrating Fresenius Kabi’s suite of cell therapy processing technologies within Cellular Origins’ CGT robotic manufacturing platform Constellation™. The aim of this work is to assist cell therapy developers manufacture their therapies at scale using their preferred processing tools.
Cellular Origins, a TTP Company, focuses on enabling scalable, cost-effective, and efficient manufacture of CGTs via its Constellation™ automation platform. Fresenius Kabi, a global health care company, specializes in products, technologies, and services for the therapy and care of patients with critical and chronic conditions.
The work will begin with a focus on the integration of Fresenius Kabi’s Cue® Cell Processing System to target an integrated and functional system to enable the Cue System to be fully automated with robotic consumable transport, connection, installation, deinstallation, full process operation and control and data management via the hardware and digital layer of Constellation. This approach is intended to create a step towards fully automated 24/7 CGT manufacturing at true scale, making maximum usage of manufacturing space with the minimal number of personnel and without process change.
Fresenius Kabi has designed its Cell Therapy Technologies portfolio to provide scalable solutions to major challenges of cell therapy research and manufacture. The companies will focus their initial integration work on the Cue Cell Processing System because it is specifically designed for automated and precise small volume cell processing. Cue’s flexible design and delivery of results across a wide a range of critical applications, including final formulation and culture media exchange, precisely and consistently, made it Fresenius Kabi’s lead candidate for integration with Cellular Origin’s Constellation.
Cellular Origins believes that successful scaling of cell therapies requires close cross-industry collaboration and as such, has prioritised developing and strengthening alliances with leading technology providers in the field. Constellation is designed to automate the manufacturing of advanced therapies without significant process redevelopment. This collaboration will allow Cellular Origins and Fresenius Kabi to harness the experience of both teams to work toward the physical and digital integration of the Cue system within Constellation. If successful, bolstering Constellation’s capabilities with fully automated cell processing could enable end users to improve production efficiencies while also reducing inconsistencies by alleviating the risk of human variation and error.
Following the focus on Cue, the collaboration contemplates focusing on Fresenius Kabi’s wider cell therapy technologies portfolio, including the Lovo® Cell Processing System and future products currently in development.
“Cellular Origins has developed Constellation to enable fully industrialised manufacture of cell and gene therapies,” said Dr Edwin Stone, CEO at Cellular Origins. “Forming strong collaborations is essential to ensuring the industry can implement the transformative power of automation whilst using the tools that are best for the biology and, therefore, for patients. Fresenius Kabi is an industry-leading developer of automated technologies to support the production of cell therapies. This is why we are excited to be working closely with their team to unlock the power of automation throughout the entire manufacturing process, with the goal of bringing life-saving therapies to patients, faster and more affordably.”
“For Fresenius Kabi, automation is crucial to addressing some of the biggest research and manufacture challenges in our industry. This is a major reason for our collaboration with Cellular Origins,” said Dr Christian Hauer, President MedTech at Fresenius Kabi. “Our cell therapy technologies are designed with automation at their core, to provide new levels of precision and efficiency. By working closely with the team at Cellular Origins, we hope to advance the CGT industry by helping therapy developers embrace automation during the production process with the goal of ultimately benefitting patients.”
