Document Detail

Quality controls in cellular immunotherapies: rapid assessment of clinical grade dendritic cells by gene expression profiling.
MedLine Citation:
PMID:  23147403     Owner:  NLM     Status:  MEDLINE    
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.
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
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Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural     Date:  2012-11-13
Journal Detail:
Title:  Molecular therapy : the journal of the American Society of Gene Therapy     Volume:  21     ISSN:  1525-0024     ISO Abbreviation:  Mol. Ther.     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-02-01     Completed Date:  2013-08-07     Revised Date:  2014-02-04    
Medline Journal Info:
Nlm Unique ID:  100890581     Medline TA:  Mol Ther     Country:  United States    
Other Details:
Languages:  eng     Pagination:  476-84     Citation Subset:  IM    
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MeSH Terms
Cell Differentiation
Computational Biology
Dendritic Cells / cytology*,  immunology*
Flow Cytometry
Gene Expression Profiling / methods*
Immunotherapy / methods*
Leukocytes, Mononuclear / cytology,  immunology
Microarray Analysis
Monocytes / cytology,  immunology
Quality Control
Erratum In:
Mol Ther. 2013 Feb;21(2):495

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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