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Current good manufacturing practice considerations for mesenchymal stromal cells as therapeutic agents

dc.contributor.authorSanz-Nogués, Clara
dc.contributor.authorO'Brien, Timothy
dc.date.accessioned2021-05-24T08:39:25Z
dc.date.available2021-05-24T08:39:25Z
dc.date.issued2021-05-05
dc.identifier.citationSanz-Nogués, Clara, & O'Brien, Timothy. (2021). Current good manufacturing practice considerations for mesenchymal stromal cells as therapeutic agents. Biomaterials and Biosystems, 2, doi:https://doi.org/10.1016/j.bbiosy.2021.100018en_IE
dc.identifier.urihttp://hdl.handle.net/10379/16778
dc.description.abstractProducing human mesenchymal stromal cells (MSCs) for clinical use requires adherence to current good manufacturing practice (cGMP) standards. This is necessary for ensuring standardization and reproducibility through the manufacturing process, but also, for product quality and safety. However, the large-scale production of clinical-grade MSCs possesses unique regulatory challenges and hurdles related to the heterogeneous nature of MSC cultures as well as the complex manufacturing process. Following is a compilation of the major issues encountered in the manufacturing of MSCs for clinical use, and our views on the optimal characteristics of the final MSC product.en_IE
dc.description.sponsorshipThis work was supported by grants from the European Commission REDDSTAR project (European Union FP7-HEALTH-F2–2012 (Grant no. 305736)); European Union Horizon 2020 project NEPHSTROM (Grant no. 634086); CURAM Centre for Research in Medical Devices (Grant no. 13/RC/2073), the European Regional Development Fund (14/IA/2884), and Science Foundation Ireland (SFI) (Grant no. 18/IF/6252).en_IE
dc.formatapplication/pdfen_IE
dc.language.isoenen_IE
dc.publisherElsevieren_IE
dc.relation.ispartofBiomaterials and Biosystemsen
dc.rightsAttribution 4.0 International (CC BY 4.0)
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.subjectMesenchymal stromal cellsen_IE
dc.subjectCell therapyen_IE
dc.subjectGood manufacturing practiceen_IE
dc.subjectClinical gradeen_IE
dc.titleCurrent good manufacturing practice considerations for mesenchymal stromal cells as therapeutic agentsen_IE
dc.typeArticleen_IE
dc.date.updated2021-05-24T08:22:32Z
dc.identifier.doi10.1016/j.bbiosy.2021.100018
dc.local.publishedsourcehttps://doi.org/10.1016/j.bbiosy.2021.100018en_IE
dc.description.peer-reviewedPeer reviewed
dc.contributor.funderSeventh Framework Programmeen_IE
dc.contributor.funderHorizon 2020en_IE
dc.contributor.funderEuropean Regional Development Funden_IE
dc.contributor.funderScience Foundation Irelanden_IE
dc.internal.rssid25992984
dc.local.contactClara Sanz Nogues, Remedi, Bioscience Building, Nui Galway. Email: clara.sanznogues@nuigalway.ie
dc.local.copyrightcheckedYes
dc.local.versionACCEPTED
dcterms.projectinfo:eu-repo/grantAgreement/EC/FP7::SP1::HEALTH/305736/EU/Repair of Diabetic Damage by Stromal Cell Administration/REDDSTARen_IE
dcterms.projectinfo:eu-repo/grantAgreement/EC/H2020::RIA/634086/EU/Novel Stromal Cell Therapy for Diabetic Kidney Disease/NEPHSTROMen_IE
dcterms.projectinfo:eu-repo/grantAgreement/SFI/SFI Research Centres/13/RC/2073/IE/C�RAM - Centre for Research in Medical Devices/en_IE
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Attribution 4.0 International (CC BY 4.0)
Except where otherwise noted, this item's license is described as Attribution 4.0 International (CC BY 4.0)