Abstract
The following commentary was developed by the National Marrow Donor Program Cord Blood Advisory Group and is intended to provide an overview of umbilical cord blood (UCB) processing, summarize the current state of potency assays used to characterize UCB, and define limitations of the assays and future needs of the cord blood banking and transplant community. The UCB banking industry is eager to participate in the development of standardized assays to uniformly characterize cellular therapy products that are manufactured in a variety of ways. This paper describes the desired qualities of these assays and how the industry proposes to co-operate with developers to bring relevant assays to market. To that end, the National Marrow Donor Program (NMDP) Cord Blood Bank Network is available to serve as a resource for UCB testing material, research and development consulting, and product/assay testing in an accredited UCB manufacturing environment.
Acknowledgement
This project has been supported by funding from the National Marrow Donor Program and the Department of the Navy, Office of Naval Research Grant #N00014-10-1-0204 and the Health Resources and Services Administration Contract No. HHSH234200637021C to the National Marrow Donor Program. Any opinions, findings, and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the Office of Naval Research or the Health Resources and Services Administration.
Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.