Ori Biotech and Fresenius Kabi Collaborate to Advance Modular, Scalable Manufacturing of Cell and Gene Therapies

LONDON, UNITED KINGDOM, and BAD HOMBURG, GERMANY, December 10, 2024 –
Ori Biotech Ltd. (Ori), a leader in cell and gene therapy (CGT) manufacturing technology, and Fresenius Kabi, an operating company of Fresenius, today announced a collaboration to integrate the IRO® platform with Fresenius Kabi’s upstream and downstream processing technologies. Through this relationship, Ori and Fresenius Kabi demonstrated that IRO can be easily and effectively integrated with the Cue® and Lovo® Cell Processing Systems to deliver an efficient and closed workflow.

“Our goal is to partner with leading technology providers that offer proven solutions for the unit operations most critical to the success, consistency, and delivery of GMP manufacturing of cell therapies,” said Jason C. Foster, CEO, Ori Biotech. “By doing the application development work to integrate the IRO with other best-in-class systems, like Cue and Lovo, we are demonstrating our commitment to delivering flexible solutions that meet the evolving needs of cell therapy manufacturing, in contrast to rigid end-to-end approaches that reduce flexibility.”

The Ori team has shown direct upstream and downstream processing integration between the IRO and the Lovo and Cue systems. For upstream processing, cells were seeded directly into the IRO consumables from the Lovo system, demonstrating a closed “Day 0” workflow and reducing dead volumes associated with existing bag-based transfers. For downstream processing, cells were harvested from the IRO bioreactor consumable directly onto the Cue system for final wash, concentration, and formulation.  The successful integration of these leading technology platforms provides a streamlined, closed workflow for cell therapy manufacturing that can reduce process steps, tube- and bag-based transfers, and operator touch time.

By developing applications and closed integrations with other technologies, such as Cue and Lovo, IRO offers manufacturers a significant step toward achieving a closed, end-to-end workflow that provides optimal flexibility and scalability while maintaining product quality and consistency.

“At Fresenius Kabi, we are focused on advancing technologies that improve the efficiency and scalability of cell and gene therapy manufacturing,” said Dr. Christian Hauer, President MedTech, Fresenius Kabi. “Our collaboration with Ori Biotech allows us to integrate their innovative IRO platform with our systems, supporting our partners’ goal of delivering life-saving cell and gene therapies to patients as quickly and consistently as possible.”

This collaboration underscores Ori Biotech and Fresenius Kabi’s shared commitment to developing widespread patient access to life-saving cell and gene therapies. Together, Ori and Fresenius Kabi are driving innovation in CGT manufacturing, with the goal of reducing barriers and helping bring cell and gene therapies to market faster and more efficiently.

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About Ori Biotech

Ori Biotech is a London and Philadelphia-based manufacturing technology company on a mission to enable widespread patient access to life-saving cell and gene therapies. IRO®, Ori’s next-generation manufacturing platform automates better biology, accelerates product development and enables therapy developers to scale their products’ clinical and commercial impact by seamlessly transitioning from R&D to GMP on one platform. The promise of the innovative Ori platform is to automate cell therapy manufacturing, increasing throughput, improving quality and decreasing costs by combining proprietary hardware, consumables, software, data and analytics.

For news and updates, visit https://oribiotech.com/press-releases.

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

Contact Information

Ori Biotech
Victoria Verdeja
Tel: 646-599-8622
Email: Media@OriBiotech.com

Fresenius Kabi
Matt Kuhn
Tel: 847-220-3033
Email: Matt.kuhn@fresenius-kabi.com