Boston Children's Hospital, Massachusetts, United States
Background/Case Studies: Apheresis collection facilities must validate collection devices and methods to ensure cell recovery meets all safety, identity, strength, purity, and quality criteria. Our site’s verification process includes qualification of supplies, materials, and equipment, and evaluation of the device’s ability to yield a product that meets objective acceptance criteria reproducibly. Process verification is critical to maintaining consistent cell collection, especially after repair or software upgrades. The aim of this study was to assess the performance of our site’s four apheresis devices and document their continued validation status before and after the device upgrade.
Study
Design/Methods: We defined performance as a retrospective quantitative analysis of cell therapy collection data one year before and after device upgrade: collection efficiency, product yield, viability, sterility, engraftment, manufacturing efficiency, and therapeutic response. Data were collected from EMR and lab reports for mobilized autologous HPC and MNC pediatric collections across solid tumor and hematologic malignancy diagnoses.
Results/Findings: In 2021-22 we harvested an HPC cell dose of ≥2.5x106/kg for all donors. The Median CE was 50.56% (18.69-120.19%); in 2022, the Median was 47.45% (27.88-119.99%). The average viability in 2021, was 98.4% (93.2-99.6%), and in 2022, 97.98% (92.5-99.6%). In 2021, two products had positive sterility results; RCA did not identify the collection process, device, or related procedures as a source of contamination. In 2022, no positive sterilities were reported. The average days to engraftment in 2021 was 11.0 (9-14d) and in 2022 was 11.3 (9-15d) with no statistically significant difference between 2021/22 (p=0.33). In 2021-22 we harvested a target MNC dose of ≥1.0 x 109 for all donors. The Median CE was Median 75.6% (64-113.7%) in 2021, and in 2022, 47.45% (27.88-119.99%). The average viability in 2021, was 99.2% (97-100%), and in 2022, 83.0% (55.8- 100.2%). In 2021 and 2022, no positive sterilities were reported, and products met CAR T-cell therapy manufacture criteria. All 2021 and 2022 CAR T therapy recipients achieved therapeutic response at 30d. Conclusions: In conclusion, we found that device performance verification is a useful tool to ensure that a collection center continues to meet the acceptance criteria of the original validation. Data before and after the device upgrade are stable and demonstrate that our collection process is consistent, resulting in products with acceptable outcomes for collection efficiency, yield, viability, sterility, engraftment, manufacturing efficiency, and therapeutic response data.
Importance of research: As apheresis collection instruments age and require repairs and software upgrades, it is critically important to review collection data to ensure the collection procedure and related processes produce consistent outcomes. We developed a tool to analyze collection efficiency, yield, viability, sterility, engraftment, manufacturing efficiency, and therapeutic response to verify our devices' performance over time. This tool is recommended after major device repair or upgrade.
