Molecular Diagnosis & Therapy

, Volume 13, Issue 3, pp 181–193

Global Transcriptional Analysis for Biomarker Discovery and Validation in Cellular Therapies

  • David F. Stroncek
  • Ping Jin
  • Ena Wang
  • Jiagiang Ren
  • Marianna Sabatino
  • Francesco M. Marincola
Review Article

DOI: 10.1007/BF03256324

Cite this article as:
Stroncek, D.F., Jin, P., Wang, E. et al. Mol Diag Ther (2009) 13: 181. doi:10.1007/BF03256324

Abstract

Potency testing is an important part of the evaluation of cellular therapy products. Potency assays are quantitative measures of a product-specific biologic activity that is linked to a relevant biologic property and, ideally, a product’s in vivo mechanism of action. Both in vivo and in vitro assays can be used for potency testing. Since there is often a limited period of time between the completion of production and the release from the laboratory for administration to the patient, in vitro assays such as flow cytometry, ELISA, and cytotoxicity are typically used. Better potency assays are needed to assess the complex and multiple functions of cellular therapy products, some of which are not well understood. Gene expression profiling using microarray technology has been widely and effectively used to assess changes of cells in response to stimuli and to classify cancers. Preliminary studies have shown that the expression of non-coding microRNA (miRNA), which plays an important role in cellular development, differentiation, metabolism, and signal transduction, can distinguish between different types of stem cells and leukocytes. Both gene and miRNA expression profiling have the potential to be important tools for testing the potency of cellular therapies. Potency testing, the complexities associated with potency testing of cellular therapies, and the potential role of gene and miRNA expression microarrays in potency testing of cellular therapies are discussed.

Copyright information

© Adis Data Information BV 2009

Authors and Affiliations

  • David F. Stroncek
    • 1
  • Ping Jin
    • 1
  • Ena Wang
    • 1
  • Jiagiang Ren
    • 1
  • Marianna Sabatino
    • 1
  • Francesco M. Marincola
    • 1
  1. 1.Department of Transfusion Medicine, Clinical CenterNational Institutes of HealthBethesdaUSA

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