Quality controls in cellular immunotherapies: Rapid assessment of clinical grade dendritic cells by gene expression profiling

Luciano Castiello, Marianna Sabatino, Yingdong Zhao, Barbara Tumaini, Jiaqiang Ren, Jin Ping, Ena Wang, Lauren V. Wood, Francesco M. Marincola, Raj K. Puri, David F. Stroncek

Research output: Contribution to journalArticle

9 Citations (Scopus)


Cell-based immunotherapies are among the most promising approaches for developing effective and targeted immune response. However, their clinical usefulness and the evaluation of their efficacy rely heavily on complex quality control assessment. Therefore, rapid systematic methods are urgently needed for the in-depth characterization of relevant factors affecting newly developed cell product consistency and the identification of reliable markers for quality control. Using dendritic cells (DCs) as a model, we present a strategy to comprehensively characterize manufactured cellular products in order to define factors affecting their variability, quality and function. After generating clinical grade human monocyte-derived mature DCs (mDCs), we tested by gene expression profiling the degrees of product consistency related to the manufacturing process and variability due to intra-and interdonor factors, and how each factor affects single gene variation. Then, by calculating for each gene an index of variation we selected candidate markers for identity testing, and defined a set of genes that may be useful comparability and potency markers. Subsequently, we confirmed the observed gene index of variation in a larger clinical data set. In conclusion, using high-throughput technology we developed a method for the characterization of cellular therapies and the discovery of novel candidate quality assurance markers.

Original languageEnglish
Pages (from-to)476-484
Number of pages9
JournalMolecular Therapy
Issue number2
Publication statusPublished - Feb 2013
Externally publishedYes


ASJC Scopus subject areas

  • Molecular Biology
  • Molecular Medicine
  • Genetics
  • Drug Discovery
  • Pharmacology

Cite this

Castiello, L., Sabatino, M., Zhao, Y., Tumaini, B., Ren, J., Ping, J., Wang, E., Wood, L. V., Marincola, F. M., Puri, R. K., & Stroncek, D. F. (2013). Quality controls in cellular immunotherapies: Rapid assessment of clinical grade dendritic cells by gene expression profiling. Molecular Therapy, 21(2), 476-484. https://doi.org/10.1038/mt.2012.89