Agilent Technologies Inc. (NYSE: A) has announced its significant contribution to the recent FDA approval of AUCATZYL®, a novel CAR T cell therapy developed by Autolus Therapeutics. The company's xCELLigence Real-Time Cell Analysis (RTCA) technology played a crucial role in developing and validating the potency assay for this innovative cancer treatment.
The xCELLigence RTCA platform provided Autolus with the precise and reliable cell analysis capabilities necessary to meet the FDA's stringent requirements for approval. This technology enables continuous monitoring of cell behavior in real-time without labels or dyes, measuring electrical impedance to deliver dynamic information on cell numbers, viability, and morphology.
"Agilent is honored to have contributed to this significant milestone in cancer treatment," said Dr. Xiaobo Wang, Vice President and General Manager of the Cell Function and Phenotyping Business at Agilent. "The collaboration between Agilent and Autolus highlights the importance of innovative technologies and cooperative efforts in advancing cancer therapies."
David Brochu, Chief Technical Officer at Autolus Therapeutics, acknowledged the critical role of Agilent's technology in their regulatory journey: "Agilent's support was invaluable in our journey to FDA approval. Agilent's state-of-the-art xCELLigence RTCA technology facilitated the accuracy, reliability and precision of our potency analytical procedure."
Advanced Cell Analysis Technology
The xCELLigence RTCA technology represents a significant advancement over traditional endpoint assays used in drug development. By providing real-time insights into cellular responses, the platform enables more accurate and timely decision-making throughout the development process.
Unlike conventional methods that capture data at specific timepoints, xCELLigence delivers continuous, real-time data on cellular behavior. This comprehensive approach gives researchers a deeper understanding of how cells respond to potential therapies, ultimately enhancing the development of effective treatments.
The technology's ability to measure electrical impedance without disrupting cellular processes offers a non-invasive method to monitor cellular activity. This feature is particularly valuable in the development of complex biological therapies like CAR T cells, where maintaining cellular integrity throughout analysis is crucial.
Industry Collaboration and Knowledge Sharing
The successful collaboration between Agilent and Autolus will be highlighted at the upcoming 2025 Hybrid US Bioassay Conference, scheduled for March 24-25 in Tucson, Arizona. Representatives from both companies will present a session titled "Lessons Learned in CAR T Cell Product Potency Measurement: A Cross-Functional Investigation and the Importance of Partnership."
Mike Merges, Vice President of Analytical Development, QC Control Operations, Automation, and CMC at Autolus, will join Jakub Dragun, Quality Control Consultant at Autolus, and Xiaobo Wang from Agilent for this presentation. The session will take place on Monday, March 24, from 1:30-2:00 PM in the Sabino Room at the Marriott Tucson University Park Hotel.
Advancing Cancer Treatment Through Technology
The FDA approval of AUCATZYL® represents a significant advancement in cancer treatment options. CAR T cell therapies have shown remarkable promise in treating various forms of cancer, particularly in patients who have exhausted other treatment options.
These therapies involve modifying a patient's own T cells to express chimeric antigen receptors (CARs) that recognize and attack cancer cells. The manufacturing and quality control of these complex cellular products require sophisticated analytical tools to ensure consistency, potency, and safety.
Agilent's xCELLigence technology addresses these challenges by providing reliable, real-time data on cellular function throughout the development and manufacturing processes. This capability is essential for meeting regulatory requirements and ensuring patient safety.
"This collaboration exemplifies how technological innovation can accelerate the development of life-saving therapies," noted an industry expert familiar with the approval. "The ability to monitor cellular responses in real-time represents a significant advantage in the development of complex biological products like CAR T cells."
Agilent Technologies, which generated revenue of $6.51 billion in fiscal year 2024 and employs approximately 18,000 people worldwide, continues to demonstrate its commitment to advancing scientific innovation in healthcare. The company's contribution to the approval of AUCATZYL® highlights the critical role that analytical technologies play in bringing novel therapies from laboratory to patient.
