Guidelines for the development and validation of new potency assays for the evaluation of umbilical cord blood.

Journal Article (Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • Spellman, S; Hurley, CK; Brady, C; Phillips-Johnson, L; Chow, R; Laughlin, M; McMannis, J; Reems, J-A; Regan, D; Rubinstein, P; Kurtzberg, J; National Marrow Donor Program Cord Blood Advisory Group,

Published Date

  • August 2011

Published In

Volume / Issue

  • 13 / 7

Start / End Page

  • 848 - 855

PubMed ID

  • 21449685

Electronic International Standard Serial Number (EISSN)

  • 1477-2566

Digital Object Identifier (DOI)

  • 10.3109/14653249.2011.571249


  • eng

Conference Location

  • England