“…Systematic studies of these variables are still needed and while some, such as cell concentration, may be of relatively low importance individually, in combination there is the potential for significant loss of cell viability. Moreover, the significance of these factors varies according to the type of product, for example, in cord blood HPCs and marrow HPCs, the total nucleated cell (TNC) count rarely exceeds 100 × 10 9 /L but the red blood cell (RBC) volume is in the range 25% to 35%, whereas apheresis HPC components may have TNC counts of greater than 200 × 10 9 /L but the RBC volume is usually less than 10% 3 . Cell therapy facilities must also comply with the regulatory requirements of the European Union (EU) and the United States Food and Drug Administration (FDA), as well as the Netcord‐FACT, FACT‐JACIE, AABB, and World Marrow Donor Association (WMDA) standards, 1,2,10‐13 which require, for example, that product temperature is maintained as specified by processing facilities during transport, that shipping facilities should maintain a record of temperature during transport, and that receiving facilities should verify and record the acceptability (i.e., integrity, appearance) of the product 1,2,10‐13 .…”