Cord Blood Donor Qualification

Cord blood (CB) donor qualification is an active process to determine suitability and safety of a CB product for the purpose of hematopoietic cell transplantation. The process commences with the recruitment and selection of a suitable donor and finishes with the CB unit (CB) meeting the requirements of pre-release testing parameters, the quality of the product ultimately confirmed by the outcomes observed posttransplant. CB is a biological product that is processed and stored for long periods of time prior to use, thereby increasing the complexity of the donor qualification process. In addition to maternal donor screening, there are many in-process parameters of the CBU that must meet compliance in order for the CBU to be deemed to be of an acceptable quality for clinical use. This chapter outlines the criteria that together are used in the process of CB donor qualification.