Comparative analysis of cell therapy infusion workflows at clinical sites

Background aims: Cell therapies are an emerging treatment option for a variety of diseases, especially with the success of chimeric antigen receptor T-cell therapies. With 18 FDA-approved cell therapy products as of December 2020 and a growing number in clinical trials, standards for most aspects of the cell therapy lifecycle are well-established by professional organizations like AABB and FACT; however, there are limited standardized protocols regarding the day-of infusion. Methods: Infusions were observed at three academic medical centers in the United States, and the workflows were analyzed and compared based on factors including facility layout, product verification processes, cryobag design, timing restrictions, and use of electronic medical records. Results: Variations between the facilities were identified with product thawing location and cell therapy lab location being the most important factors in time from thaw to infusion. Conclusions: Based on this analysis, opportunities were identified for standardization and streamlining the infusion workflow which may help facilitate adoption of new and existing cell therapies at a wider range of hospitals. ? 2021 International Society for Cell & Gene Therapy. Published by Elsevier Inc. All rights reserved.

Automated summary

Cell therapies are a promising treatment option for various diseases, and standards for most aspects of the cell therapy lifecycle have been established, but there are limited standardized protocols regarding the day-of infusion. Variations were identified in facility layout, product thawing location, and cell therapy lab location, which influenced the time from thaw to infusion. Opportunities for standardizing and streamlining the infusion workflow were identified to facilitate adoption of cell therapies at more hospitals.