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Article: Translating mesenchymal stem cell and their exosome research into GMP compliant advanced therapy products: Promises, problems and prospects

TitleTranslating mesenchymal stem cell and their exosome research into GMP compliant advanced therapy products: Promises, problems and prospects
Authors
Keywordsclinical translation
exosomes
good manufacturing practice
mesenchymal stem cells
therapeutic products
Issue Date14-Dec-2023
PublisherWiley
Citation
Medicinal Research Reviews, 2023 How to Cite?
Abstract

Mesenchymal stem cells (MSCs) are one of the few stem cell types used in clinical practice as therapeutic agents for immunomodulation and ischemic tissue repair, due to their unique paracrine capacity, multiple differentiation potential, active components in exosomes, and effective mitochondria donation. At present, MSCs derived from tissues such as bone marrow and umbilical cord are widely applied in preclinical and clinical studies. Nevertheless, there remain challenges to the maintenance of consistently good quality MSCs derived from different donors or tissues, directly impacting their application as advanced therapy products. In this review, we discuss the promises, problems, and prospects associated with translation of MSC research into a pharmaceutical product. We review the hurdles encountered in translation of MSCs and MSC-exosomes from the research bench to an advanced therapy product compliant with good manufacturing practice (GMP). These difficulties include how to set up GMP-compliant protocols, what factors affect raw material selection, cell expansion to product formulation, establishment of quality control (QC) parameters, and quality assurance to comply with GMP standards. To avoid human error and reduce the risk of contamination, an automatic, closed system that allows real-time monitoring of QC should be considered. We also highlight potential advantages of pluripotent stem cells as an alternative source for MSC and exosomes generation and manufacture.


Persistent Identifierhttp://hdl.handle.net/10722/339697
ISSN
2023 Impact Factor: 10.9
2023 SCImago Journal Rankings: 2.864
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorMa, CY-
dc.contributor.authorZhai, YQ-
dc.contributor.authorLi, CT-
dc.contributor.authorLiu, J-
dc.contributor.authorXu, X-
dc.contributor.authorChen, H-
dc.contributor.authorTse, HF-
dc.contributor.authorLian, QZ-
dc.date.accessioned2024-03-11T10:38:40Z-
dc.date.available2024-03-11T10:38:40Z-
dc.date.issued2023-12-14-
dc.identifier.citationMedicinal Research Reviews, 2023-
dc.identifier.issn0198-6325-
dc.identifier.urihttp://hdl.handle.net/10722/339697-
dc.description.abstract<p>Mesenchymal stem cells (MSCs) are one of the few stem cell types used in clinical practice as therapeutic agents for immunomodulation and ischemic tissue repair, due to their unique paracrine capacity, multiple differentiation potential, active components in exosomes, and effective mitochondria donation. At present, MSCs derived from tissues such as bone marrow and umbilical cord are widely applied in preclinical and clinical studies. Nevertheless, there remain challenges to the maintenance of consistently good quality MSCs derived from different donors or tissues, directly impacting their application as advanced therapy products. In this review, we discuss the promises, problems, and prospects associated with translation of MSC research into a pharmaceutical product. We review the hurdles encountered in translation of MSCs and MSC-exosomes from the research bench to an advanced therapy product compliant with good manufacturing practice (GMP). These difficulties include how to set up GMP-compliant protocols, what factors affect raw material selection, cell expansion to product formulation, establishment of quality control (QC) parameters, and quality assurance to comply with GMP standards. To avoid human error and reduce the risk of contamination, an automatic, closed system that allows real-time monitoring of QC should be considered. We also highlight potential advantages of pluripotent stem cells as an alternative source for MSC and exosomes generation and manufacture.</p>-
dc.languageeng-
dc.publisherWiley-
dc.relation.ispartofMedicinal Research Reviews-
dc.rightsThis work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.-
dc.subjectclinical translation-
dc.subjectexosomes-
dc.subjectgood manufacturing practice-
dc.subjectmesenchymal stem cells-
dc.subjecttherapeutic products-
dc.titleTranslating mesenchymal stem cell and their exosome research into GMP compliant advanced therapy products: Promises, problems and prospects-
dc.typeArticle-
dc.identifier.doi10.1002/med.22002-
dc.identifier.pmid38095832-
dc.identifier.scopuseid_2-s2.0-85179950181-
dc.identifier.eissn1098-1128-
dc.identifier.isiWOS:001124224400001-
dc.publisher.placeHOBOKEN-
dc.identifier.issnl0198-6325-

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