On Nov. 23, 2020 a new collection label standard for Cell Therapy Manufacturing was released by ICCBBA with the intent of addressing the inconsistencies found in labeling apheresis collection products for sponsor cellular therapy clinical trials and manufacturing. This new standard aims to reduce the risk of misinterpretation of patient data while providing consistency in labeling requirements to collection centers.
Overall, the new label helps to ensure essential ISBT 128 traceability information is retained, while also accommodating sponsor/manufacturer information in a standardized manner. It defines the labeling requirements for cellular therapy apheresis collection products for further processing by a clinical trials sponsor or a manufacturer and is for use only in situations where the sponsor/manufacturer has adopted this standard and has provided the necessary information to populate the sponsor/manufacturer section of the label.
STEMSOFT remains committed to supporting all cellular therapy labeling standards and will be introducing this new ISBT Collection Label template in our next STEMSOFT LAB release.