title: Quality Control Assays for Clinical-Grade Human Mesenchymal Stromal Cells: Validation Strategy.
abstract: The present chapter focuses on the validation of the following analytical methods for the control of mesenchymal stromal cells (MSC) for cell therapy clinical trials: Microbiological control for cellular product Endotoxin assay Mycoplasma assay Cell count and viability Immunophenotype Clonogenic potential (CFU-F assay) In our lab, these methods are in use for product release, process control or control of the biological starting materials. They are described in detail in the accompanying Chapter 19.For each method, validation goals and strategy are presented, and a detailed experimental scheme is proposed.
authors.affiliation: Lugano Cell Factory, Cardiocentro Ticino - Swiss Institute of Regenerative Medicine (SIRM), Via Tesserete 48, Lugano, 6900, Switzerland.
authors.forename: Marina
authors.initials: M
authors.lastname: Radrizzani
authors.affiliation: Lugano Cell Factory, Cardiocentro Ticino - Swiss Institute of Regenerative Medicine (SIRM), Via Tesserete 48, Lugano, 6900, Switzerland.
authors.forename: Sabrina
authors.initials: S
authors.lastname: Soncin
authors.affiliation: Lugano Cell Factory, Cardiocentro Ticino - Swiss Institute of Regenerative Medicine (SIRM), Via Tesserete 48, Lugano, 6900, Switzerland.
authors.forename: Sara
authors.initials: S
authors.lastname: Bolis
authors.affiliation: Lugano Cell Factory, Cardiocentro Ticino - Swiss Institute of Regenerative Medicine (SIRM), Via Tesserete 48, Lugano, 6900, Switzerland.
authors.forename: Viviana
authors.initials: V
authors.lastname: Lo Cicero
authors.affiliation: Lugano Cell Factory, Cardiocentro Ticino - Swiss Institute of Regenerative Medicine (SIRM), Via Tesserete 48, Lugano, 6900, Switzerland.
authors.forename: Gabriella
authors.initials: G
authors.lastname: Andriolo
authors.affiliation: Lugano Cell Factory, Cardiocentro Ticino - Swiss Institute of Regenerative Medicine (SIRM), Via Tesserete 48, Lugano, 6900, Switzerland. lucia.turchetto@cardiocentro.org.
authors.forename: Lucia
authors.initials: L
authors.lastname: Turchetto
mesh_terms: D001419:Bacteria / Q000302:isolation & purification; D002452:Cell Count; D018929:Cell Culture Techniques / Q000379:methods; D002470:Cell Survival; D002478:Cells, Cultured; D004731:Endotoxins / Q000032:analysis*; D006801:Humans; D016130:Immunophenotyping; D059630:Mesenchymal Stem Cells / Q000166:cytology* / Q000382:microbiology; D008828:Microbiological Techniques; D009174:Mycoplasma / Q000302:isolation & purification; D011786:Quality Control
chemical_list: D004731:Endotoxins
keywords: Accuracy; Advanced therapy medicinal products (ATMP); CFU-F assay; Detection limit; Endotoxin; Good manufacturing practice (GMP); Immunophenotype; Microbiological control for cellular product; Mycoplasma assay; Potency assays; Precision; Quality control assays; Quantitative assays; Specificity; Viability