Broadening access to cell and gene therapies through manufacturing innovation

Cell and gene therapies are transforming medicine through highly personalized treatments. Making these treatments more broadly affordable and accessible to patients requires manufacturing processes that are efficient, consistent, and scalable. Fresenius Kabi MedTech contributes to addressing this challenge with integrated cell processing solutions intended to help automate critical manufacturing steps and reduce labor-intensive and highly variable manual tasks. From cell washing and concentration to final product dose preparation, our technologies help therapy developers and manufacturers scale production while maintaining process consistency.

Researchers and scientists are finding ways to address diseases that previously had limited treatment options, and even to cure previously incurable diseases, using a patient’s own cells through cell and gene therapy. As demand for these therapies continues to grow with applications in broader disease areas, and as developers work to bring these personalized therapies to more patients, manufacturing remains one of the industry’s most significant challenges. Complex workflows, manual processing steps and the need for consistent product quality can make scaling production difficult, with manufacturers facing increasing pressure to improve efficiency, consistency and scalability while reducing complexity and cost.1 

Automation is a critical element in expanding production capacity and enabling broader patient access to these potentially transformational therapies. Fresenius Kabi supports the advancement of cell and gene therapies by providing solutions that help enable efficient, standardized and scalable manufacturing. We provide automated cell processing systems used by pharmaceutical manufacturers, biotechnology companies, research organizations and healthcare institutions throughout the cell therapy manufacturing process.

A healthcare or laboratory professional interacts with the touchscreen interface of a medical processing device. Tubing and multiple processing channels are visible.

150+ 
cell and gene therapies approved2

4,400+ 
cell and gene therapies in development2

100+ 
diseases targeted by current cell and gene therapy pipeline3

Enabling industrialization: scalable cell therapy manufacturing

Fresenius Kabi’s solutions support critical cell therapy manufacturing process steps, helping therapy developers move from labor-intensive manual workflows toward greater end-to-end automation.

  • Lovo Cell Processing System: automated platform for cell washing and concentration buffer exchange
  • Cue Cell Processing System: automated platform for wash, concentrate, formulate and fill

These systems are used in a variety of applications, including treatments that use living immune cells that are collected, modified or expanded and administered to patients to attack diseased cells (CAR-T, TCR-T and natural killer cell therapies), and therapies that use stem cells, which can self-renew and develop into specialized cell types, to repair, replace or regenerate damaged tissues and cells.1,4

Close-up view of automated laboratory equipment with robotic and mechanical components used in a controlled clinical or manufacturing environment.

By automating key manufacturing steps, our solutions can help improve workflow standardization while supporting reproducibility across therapy developers’ manufacturing sites.

Advancing robotics-operated automation and scalability

Fresenius Kabi continues to invest in technologies and collaborations aimed at advancing robotics-operated automated manufacturing, as well as exploring new approaches that scale and expand manufacturing to bring therapies closer to patients.

  • A partnership with Cellular Origins integrates Fresenius Kabi cell processing technologies in robotic manufacturing platforms designed to support fully automated and scalable production environments.5
  • A strategic collaboration with TQ Therapeutics focuses on incorporating novel cell selection column technology into the Cue Cell Processing System to support efficient, high-purity T-cell isolation workflows.6
  • Decentralized manufacturing models have the potential to shorten vein-to-vein timelines and improve patient access. As part of the EU-funded EASYGEN consortium, Fresenius Kabi joins other organizations aiming to develop modular manufacturing concepts to support hospital-based production of personalized CAR-T therapies.7

As cell and gene therapies continue to evolve, Fresenius Kabi remains focused on developing and providing technologies that can help manufacturers improve efficiency, standardize workflows, and scale production to meet future demand. By helping automate critical manufacturing processes, Fresenius Kabi supports the infrastructure behind the development and production of advanced cell and gene therapies – by contributing to a more scalable and efficient future for personalized medicine aimed at creating  broader patient access.

FAQ

Cell therapy manufacturing is the process of collecting, enriching, modifying, expanding, and preparing cells for therapeutic use.

Automation can help reduce manual handling, improve process consistency, and support scalable production.

Fresenius Kabi provides automated cell processing technologies used during manufacturing but does not develop and manufacture therapies.

Examples include CAR-T therapies, TCR-T therapies, natural killer (NK) cell therapies, and stem cell-based therapies.

Disclaimer

Products described are medical devices. Availability, indications for use, and regulatory status may vary by country. Please contact your local Fresenius Kabi representative for product-specific information and availability in your market.

The Lovo Cell Processing System is for non-clinical laboratory and research use only. User must obtain appropriate regulatory clearance for clinical use. Refer to the LOVO Cell Processing System Operator's Manual for a complete list of warnings and cautions

The Cue® Cell Processing System is for laboratory use only and may not be used for direct transfusion. Refer to the Cue System User's Guide for a complete list of warnings and precautions associated with the use of this product

References

1. Sanomachi T, Katsuya Y, Nakatsura T, Koyama T. Next-Generation CAR-T and TCR-T Cell Therapies for Solid Tumors: Innovations, Challenges, and Global Development Trends. Cancers. 2025;17(12):1945. https://www.mdpi.com/2072-6694/17/12/1945

2. American Society of Gene & Cell Therapy (ASGCT) and Citeline. Q2 2026 Quarterly Report: Gene, Cell, + RNA Therapy Landscape. June 2026. Available at: ASGCT Q2 2026 Report

3. Barrett, D., & Digaudio, D. (2025). The landscape of cell and gene therapy today. Molecular therapy: the journal of the American Society of Gene Therapy, 33(6), 2316–2323. https://doi.org/10.1016/j.ymthe.2025.05.006

4. National Institutes of Health (NIH), Stem Cell Basics. https://stemcells.nih.gov/info/basics/stc-basics

5. Fresenius Kabi. Press release: Cellular Origins, Fresenius Kabi Sign Development Agreement for Scalable Automation of Cell and Gene Therapy Manufacturing. https://www.fresenius-kabi.com/news/scalable-automation-of-cell-and-gene-therapy-manufacturing

6. Fresenius Kabi. Press release: Fresenius Kabi, TQ Therapeutics Announce Cell Therapy Technology Agreement. https://www.fresenius-kabi.com/us/news-and-events/cell-therapy-technology-agreement

7. Fresenius Kabi. News: Fresenius Leads New EASYGEN Consortium Aimed at Decentralizing CAR-T Cell Therapy and Improving Hospital Workflows. https://www.fresenius-kabi.com/news/fresenius-leads-new-easygen-consortium