GMP Tiered Cell Banking of Non-enzymatically Isolated Dermal Progenitor Fibroblasts for Allogenic Regenerative Medicine.

Details

Serval ID
serval:BIB_66D94F68D9E8
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
GMP Tiered Cell Banking of Non-enzymatically Isolated Dermal Progenitor Fibroblasts for Allogenic Regenerative Medicine.
Journal
Methods in molecular biology
Author(s)
Laurent A., Scaletta C., Michetti M., Hirt-Burri N., de Buys Roessingh A.S., Raffoul W., Applegate L.A.
ISSN
1940-6029 (Electronic)
ISSN-L
1064-3745
Publication state
Published
Issued date
2021
Peer-reviewed
Oui
Volume
2286
Pages
25-48
Language
english
Notes
Publication types: Journal Article
Publication Status: ppublish
Abstract
Non-enzymatically isolated primary dermal progenitor fibroblasts derived from fetal organ donations are ideal cell types for allogenic musculoskeletal regenerative therapeutic applications. These cell types are differentiated, highly proliferative in standard in vitro culture conditions and extremely stable throughout their defined lifespans. Technical simplicity, robustness of bioprocessing and relatively small therapeutic dose requirements enable pragmatic and efficient production of clinical progenitor fibroblast lots under cGMP standards. Herein we describe optimized and standardized monolayer culture expansion protocols using dermal progenitor fibroblasts isolated under a Fetal Transplantation Program for the establishment of GMP tiered Master, Working and End of Production cryopreserved Cell Banks. Safety, stability and quality parameters are assessed through stringent testing of progeny biological materials, in view of clinical application to human patients suffering from diverse cutaneous chronic and acute affections. These methods and approaches, coupled to adequate cell source optimization, enable the obtention of a virtually limitless source of highly consistent and safe biological therapeutic material to be used for innovative regenerative medicine applications.
Keywords
Biological Specimen Banks/standards, Cells, Cultured, Dermis/cytology, Fibroblasts/cytology, Humans, Practice Guidelines as Topic, Primary Cell Culture/methods, Primary Cell Culture/standards, Regenerative Medicine/methods, Regenerative Medicine/standards, Stem Cell Transplantation/methods, Stem Cell Transplantation/standards, Tissue Preservation/methods, Tissue Preservation/standards, Transplantation, Homologous/methods, Transplantation, Homologous/standards, Cell therapy, Clinical cell banking, Dermal fibroblasts, GMP manufacturing, Optimized protocols, Organ donation, Progenitor cells, Safety testing
Pubmed
Web of science
Create date
26/05/2020 7:17
Last modification date
04/09/2021 5:34
Usage data