title: GMP-Grade mRNA Electroporation of Dendritic Cells for Clinical Use.
abstract: mRNA-electroporated dendritic cells (DC) are demonstrating clinical benefit in patients in many therapeutic areas, including cancer and infectious diseases. According to current good manufacturing guidelines, cell-based medicinal products have to be defined for identity, purity, potency, stability, and viability. In order to comply with the directives and guidelines defined by the regulatory authorities, we report here a standardized and reproducible method for the manufacturing of clinical-grade mRNA-transfected DC.
authors.affiliation: Laboratory of Experimental Hematology, Vaccine & Infectious Disease Institute (VAXINFECTIO), Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp University Hospital (UZA), Wilrijkstraat 10, B-2650, Edegem, Belgium.
authors.forename: Judith
authors.initials: J
authors.lastname: Derdelinckx
authors.affiliation: Laboratory of Experimental Hematology, Vaccine & Infectious Disease Institute (VAXINFECTIO), Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp University Hospital (UZA), Wilrijkstraat 10, B-2650, Edegem, Belgium.
authors.forename: Zwi N
authors.initials: ZN
authors.lastname: Berneman
authors.affiliation: Laboratory of Experimental Hematology, Vaccine & Infectious Disease Institute (VAXINFECTIO), Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp University Hospital (UZA), Wilrijkstraat 10, B-2650, Edegem, Belgium. nathalie.cools@uza.be.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Cools
mesh_terms: D018929:Cell Culture Techniques; D049109:Cell Proliferation; D002470:Cell Survival; D064987:Cell- and Tissue-Based Therapy; D002478:Cells, Cultured; D015925:Cryopreservation; D003713:Dendritic Cells / Q000166:cytology* / Q000378:metabolism; D018274:Electroporation / Q000379:methods*; D019983:Guideline Adherence; D006801:Humans; D012333:RNA, Messenger / Q000378:metabolism*
chemical_list: D012333:RNA, Messenger
keywords: Cell therapy; Dendritic cells; Electroporation; Good manufacturing practices (GMP); mRNA