title: A Review of Research-Grade Human Induced Pluripotent Stem Cells Qualification and Biobanking Processes.
abstract: Human induced pluripotent stem cell (hiPSC) biobanks are invaluable resources for basic and clinical research, since they provide a sustainable supply of accessible cell lines that meet high quality and safety standards. hiPSCs are particularly useful for understanding disease mechanisms, creating cell models for drug development, and generating novel clinical therapies. For clinical applications and drug discovery, it is fundamental that the acquired pluripotent cell lines never touch animal-derived products nor xenogeneic reagents (Good Manufacturing Practice-grade); whereas for research grade, it is sufficient to operate under Good Laboratory Practice conditions. However, regardless of the end use, it is important that every step in the whole process, starting from the original cells throughout expansion and manipulation, must be performed and recorded rigorously. Here, we describe our biobanking management system that is applied specifically to human pluripotent stem cells.
authors.affiliation: 1 Integrated Systems Engineering S.r.l. (ISENET) , Milan, Italy .
authors.forename: Aikaterini
authors.initials: A
authors.lastname: Ntai
authors.affiliation: 2 Institute of Genetic and Biomedical Research , National Research Council (IRGB-CNR), Department of Biomedicine, Milan, Italy .
authors.forename: Simona
authors.initials: S
authors.lastname: Baronchelli
authors.affiliation: 2 Institute of Genetic and Biomedical Research , National Research Council (IRGB-CNR), Department of Biomedicine, Milan, Italy .
authors.forename: Alberto
authors.initials: A
authors.lastname: La Spada
authors.affiliation: 3 Genomnia S.r.l. , Milan, Italy .
authors.forename: Anna
authors.initials: A
authors.lastname: Moles
authors.affiliation: 3 Genomnia S.r.l. , Milan, Italy .
authors.forename: Alessandro
authors.initials: A
authors.lastname: Guffanti
authors.affiliation: 1 Integrated Systems Engineering S.r.l. (ISENET) , Milan, Italy .
authors.forename: Pasquale
authors.initials: P
authors.lastname: De Blasio
authors.affiliation: 2 Institute of Genetic and Biomedical Research , National Research Council (IRGB-CNR), Department of Biomedicine, Milan, Italy .|4 IRCCS MultiMedica , Department of Stem Cell Research, Milan, Italy .
authors.forename: Ida
authors.initials: I
authors.lastname: Biunno
mesh_terms: D018070:Biological Specimen Banks / Q000592:standards*; D006801:Humans; D057026:Induced Pluripotent Stem Cells; D012106:Research / Q000592:standards*; D013048:Specimen Handling / Q000592:standards* / Q000639:trends
keywords: cell banking; human induced pluripotent stem cells; quality control