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Cited by 12CAR-T cell therapy researchHematopoietic Stem Cell TransplantationVirus-based gene therapy research

Quality assessment of cellular therapies: the emerging role of molecular assays

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Stroncek, David F., Jin, Ping, Ren, Jiaqiang, Feng, Ji, Castiello, Luciano, Civini, Sara, Wang, Ena, Marincola, Francesco M. +1 more·2010·The Korean Journal of Hematology
DOI 10.5045/kjh.2010.45.1.14PMC PMC2983004
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Abstract

Cellular therapies are becoming increasingly important in treating cancer, hematologic malignancies, autoimmune disorders, and damaged tissue. These therapies are becoming more effective and are being used more frequently, but they are also becoming more complex. As a result, quality testing is becoming an increasingly important part of cellular therapy. Cellular therapies should be tested at several points during their production. The starting material, intermediate products and the final product are usually analyzed. Products are evaluated at critical steps in the manufacturing process and at the end of production prior to the release of the product for clinical use. In addition, the donor of the starting biologic material is usually evaluated. The testing of cellular therapies for stability, consistency, comparability and potency is especially challenging. We and others have found that global gene and microRNA expression analysis is useful for comparability testing and will likely be useful for potency, stability and consistency testing. Several examples of the use of gene expression analysis for assessing cellular therapies are presented.

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Cited by

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Authors
Stroncek, D. F., Jin, P., Ren, J., Feng, J., Castiello, L., Civini, S., Wang, E., Marincola, F. M., & Sabatino, M.
Affiliations
National Institutes of Health (US)
Corresponding author
Stroncek, David F.
ORCID
Venue
The Korean Journal of Hematology
Publisher
Springer Science and Business Media LLC
Published
2010
Volume
45
Issue
1
Pages
14
ISSN
1738-7949 (ISSN-L)
DOI
10.5045/kjh.2010.45.1.14
PMC
PMC2983004
OpenAlex
W2109497380
Cited by
12
References
0
Citations by year
2026: 1 · 2025: 1 · 2024: 2 · 2023: 1 · 2022: 1 · 2020: 1 · 2017: 1 · 2014: 1 · 2012: 2
FWCI
0.47
Type
journal article
Language
en
Open access
Licence
Locations
  • The Korean Journal of Hematology (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Oncology › CAR-T cell therapy research
  • Health Sciences › Medicine › Hematology › Hematopoietic Stem Cell Transplantation
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Virus-based gene therapy research
Keywords
cell therapy, quality assessment, molecular assays, gene expression analysis, microRNA expression, potency assay, stability testing, consistency testing, donor evaluation, cell manufacturing, hematopoietic stem cell transplantation

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