title: Guidelines for the development and validation of new potency assays for the evaluation of umbilical cord blood.
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.
authors: Center for International Blood and Marrow Transplantation Research, Minneapolis, Minnesota 55413, USA. sspellma@nmdp.org
authors: Stephen
authors: S
authors: Spellman
authors: Carolyn K
authors: CK
authors: Hurley
authors: Colleen
authors: C
authors: Brady
authors: Lisa
authors: L
authors: Phillips-Johnson
authors: Robert
authors: R
authors: Chow
authors: Mary
authors: M
authors: Laughlin
authors: John
authors: J
authors: McMannis
authors: Jo-Anna
authors: JA
authors: Reems
authors: Donna
authors: D
authors: Regan
authors: Pablo
authors: P
authors: Rubinstein
authors: Joanne
authors: J
authors: Kurtzberg
mesh_terms: D001681:Biological Assay / Q000379:methods* / Q000592:standards*; D001771:Blood Banks / Q000592:standards; D017690:Cell Transplantation / Q000379:methods; D005312:Fetal Blood; D006801:Humans; D015203:Reproducibility of Results