Donor materials serve as the starting raw materials in the production process of immune cell products, and their quality is an important component in determining the quality of finished immune cell products. The management of donor materials requires cooperation between the collection unit (generally a medical institution), transportation unit and production unit, which puts forward new management requirements for production units, transportation units and medical institutions. Donor materials are derived from human bodies and may contain infectious pathogens, posing biosafety risks. At the same time, temperature has a significant impact on the quality of donor materials; in addition, during large-volume clinical trials and commercial production, it is very likely that the same medical institution will exist on the same day. When multiple batches of donor materials are collected, the risk of batch confusion is higher. In view of the above characteristics and risks of donor materials for immune cell products, this document is specially formulated to standardize the process control of donor materials from collection, transportation, acceptance and waste disposal, and to ensure the quality of donor materials.
T/ZSA 150-2023 history
2023T/ZSA 150-2023 Management requirements for donor materials of immune cell product