Impact of CAR-T cell preparation procedures on the hospital pharmacist workload: A three-year retrospective comparative study between axicabtagene ciloleucel and lisocabtagene maraleucel

Introduction/Objectives
Axicabtagene ciloleucel (axi-cel) and lisocabtagene maraleucel (liso-cel) are two CAR-T cell products approved for diffuse large B-cell lymphoma. Liso-cel is preferred at our institution due to its better safety profile, but their compounding processes differ: axi-cel requires thawing only, while liso-cel involves a dose preparation step requiring a dual verification and greater use of pharmacy resources. This study aimed to assess the impact of these differences on pharmacist workload by measuring compounding time.

Materials/Methods
A retrospective observational study was conducted among patients who received either axi-cel or liso-cel between 2023 and 2025. Compounding times were extracted from batch records and included all preparation and traceability steps performed on the day of infusion (Day 0). Durations were compared using statistical tests (α = 0.05).

Results
A total of 96 preparations were analyzed: 58 axi-cel (n = 31 in 2023; n = 19 in 2024; n = 8 in 2025) and 38 liso-cel (n = 2 in 2023; n = 13 in 2024; n = 23 in 2025). Mean total compounding time was 72 ± 11.0 min for axi-cel versus 160 ± 15.2 min for liso-cel, a statistically significant difference of 88 minutes (p < 0.001), corresponding to a 122% increase. Preparation times remained stable over the three years for axi-cel (2023: 73.4 ± 14.3; 2024: 71.2 ± 4.7; 2025: 68.5 ± 4.9; p = 0.51) and liso-cel (2023: 161.0 ± 5.7; 2024: 165.1 ± 20.3; 2025: 157.0 ± 11.6; p = 0.31).

Discussion/Conclusion
The compounding time of liso-cel was more than twice that of axi-cel, driven by the syringe-filling step following thawing. Over the past three years, liso-cel became the predominant CAR-T cell product prepared at our center, increasing the overall time devoted to CAR-T cell preparation. As liso-cel requires two pharmacy staff members, workload is further amplified. The stability of compounding times indicates that experience has not led to process optimization. Only one pharmacist is currently dedicated to Advanced Therapy Medicinal Products (ATMPs) compounding, while high turnover among staff members acting as the second operator limited the development of sustained expertise in the preparation process.
This study covers only a subset of ATMPs prepared at our center and excludes ancillary activities such as quality assurance, supply chain management, and implementation of new ATMP workflows. These findings highlight the need to reassess human resource allocation in response to the higher workload and increasing use of liso-cel. Dedicated pharmacy workload indicators specific to ATMPs are needed to better monitor this activity.

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