Cellular Origins, Fresenius Kabi Sign Development Agreement for Scalable Automation of Cell and Gene Therapy Manufacturing

Barchart · 10/16 10:04

Cellular Origins and Fresenius Kabi, an operating company of Fresenius, announce 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 to 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 has begun 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 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. Bolstering Constellation’s capabilities with fully automated cell processing will 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 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.”

About Cellular Origins www.cellularorigins.com

Cellular Origins, a TTP Company, is focused on enabling scalable, reproduceable and efficient manufacture of cell and gene therapies (CGTs).

Despite the incredible potential for CGTs in the treatment of disease, emerging therapies remain unavailable to many patients due to insufficient expertise and manufacturing capability for affordable production. With an increasing number of approved CGTs currently reaching the market, the disconnect between innovative therapies and manufacturing capabilities has led to an urgent need for solutions that provide large-scale access to cost-effective, next-generation therapeutics.

Created to provide therapeutic developers and CDMOs access to the equipment they want, at the scale they need, Cellular Origins is bringing advanced automation from the industry 4.0 revolution to the forefront of CGT.

Cellular Origins’ Constellation is a closed, configurable, robotic platform that enables scalable, reproduceable, cost-effective and space efficient advanced therapy manufacture, consisting of highly flexible mobile robots with proprietary future-proofed, automated effectors for sterile fluid transfer. The modular platform can be seamlessly integrated into new and existing workflows with minimal changes, alleviating the need for process redevelopment without constraining innovation.

To find out more about Cellular Origins and its innovative cell therapy manufacture solutions, please visit https://cellularorigins.com/. Follow Cellular Origins on X (@CellularOrigins) and LinkedIn (@CellularOrigins).

About Fresenius Kabi

As a global health care company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 43,000 employees and present in over 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.

In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status – notably as the only corporation offering both product groups. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is a global leader in supplying blood collection bags and devices, supporting blood banks and health care facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care.

Fresenius Kabi takes a holistic approach to health care and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of almost 450 million patients annually. With Vision 2026, as part of the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of health care.

Fresenius Kabi is an operating company of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing health care solutions on a global scale.

The Cue Cell Processing System is for laboratory use only and may not be used for direct transfusion. Appropriate regulatory clearance is required by the user for clinical use.

Refer to the Cue Cell Processing System Operator’s Manual for a complete list of warnings and precautions associated with the use of this product.

For more information, please visit www.fresenius-kabi.com.

This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release.

Management Board: Pierluigi Antonelli (Chairman), Marc Crouton, Andreas Duenkel, Dr. Christian Hauer, Dr. Marc-Alexander Mahl, Dr. Sang-Jin Pak

Chairman of the Supervisory Board: Wolfgang Kirsch

Registered Office: Bad Homburg, Germany

Commercial Register: Amtsgericht Bad Homburg - HRB 11654