
Driving patient safety in CAR-T therapy production
When a global pharmaceutical giant set its sights on expanding into CAR-T therapies, Agidens joined forces with them. We stepped in, helping turn ambition into reality by validating systems, qualifying equipment and ensuring every piece of the puzzle met the highest standards. Our work was pivotal at Europe’s largest CAR-T production facility, where every test, every protocol and every check brought us one step closer to what truly matters: patient safety.

SUPPORTING CAR-T CELL THERAPY PRODUCTION
From the beginning, Agidens helped shape the commissioning and qualification strategy, resulting in a well-defined project and qualification plan.
To efficiently manage multiple similar systems, a grouping strategy was put in place, streamlining qualification for systems with shared features. As new facilities were built, an “out-of-place qualification” approach allowed certain qualification tasks to be completed outside the final operating environment when appropriate.
This approach helped us navigate the complexity of managing numerous similar systems, ensuring that qualification stayed efficient, compliant and seamless as the facility expanded.
We developed a detailed Validation Master Plan to keep the project on schedule, meet the highest quality standards and comply with Good Manufacturing Practice (GMP) regulations.
Agidens contributed significantly in three critical areas:
CAR-T therapy stands as a transformative breakthrough in cancer treatment. Unlike traditional therapies, CAR-T is tailored specifically to each patient: T-cells are collected from the patient, genetically modified in a laboratory and reintroduced into the body to precisely target and destroy cancer cells.
This highly personalized treatment approach brings renewed hope to patients who have exhausted other options, offering them a fighting chance against this challenging disease.
- Commissioning & Qualification (C&Q) of facilities
Covering one laboratory and two production sites; one dedicated to clinical studies and another for large-scale production. - Analytical Instrument Qualification (AIQ)
Ensuring all analytical and laboratory equipment met the stringent standards essential for CAR-T production. - Process Equipment Validation
Conducting comprehensive testing and qualification of the production equipment.
Commissioning & Qualification
Through precise validation of three CAR-T therapy facilities, Agidens ensured compliance across sites by setting clear requirements and rigorously inspecting each area. Rooms with varying cleanliness grades (B, C, D) were validated, along with the essential utilities required to maintain these controlled environments. This included thorough testing of biological safety cabinets, monitoring systems and PLCs.
- 3 buildings qualified (Lab and Production)
- Supporting the release of the largest CAR-T facility in Europe
Analytical Instrument Qualification
An innovative “grouping” strategy streamlined equipment validation, reducing the testing load while maintaining high quality standards. Implementing the Kneat paperless software further enhanced efficiency, enabling seamless digital management, improved traceability, and full regulatory compliance—entirely without physical documents.
- +30 equipment types, ranging from complex (C) to simple (A)
- +320 pieces of equipment
- +400 documents created
- +600 documents not created by using the grouping strategy
Process Equipment Validation
By applying a Risk-Based Qualification approach, we supported the validation of Europe’s largest cryopreservation facility, focusing on process equipment and CTUs. Our Testing and Inspection Services (TIS) team provided essential test equipment, such as data loggers, and conducted comprehensive CTU testing. A “grouping” strategy further optimized testing, ensuring full regulatory compliance.
- +220 protocols executed, reviewed and approved
- +180 CTUs tested (ranging from Liquid Nitrogen freezers to incubators)
By guiding the validation and qualification process, we helped advance cancer treatment with our expertise in commissioning, analytical instrument qualification and risk-based validation. Together with the client, we created a safe and efficient environment for producing personalized life-saving therapies.