Quality Control Assays for Clinical-Grade Human Mesenchymal Stromal Cells: Validation Strategy.

Radrizzani, Marina; Soncin, Sabrina; Bolis, Sara; Lo Cicero, Viviana; Andriolo, Gabriella; Turchetto, Lucia

Radrizzani, Marina; Soncin, Sabrina; Bolis, Sara; Lo Cicero, Viviana; Andriolo, Gabriella; Turchetto, Lucia.

Afiliación

Radrizzani M; Lugano Cell Factory, Cardiocentro Ticino - Swiss Institute of Regenerative Medicine (SIRM), Via Tesserete 48, Lugano, 6900, Switzerland.
Soncin S; Lugano Cell Factory, Cardiocentro Ticino - Swiss Institute of Regenerative Medicine (SIRM), Via Tesserete 48, Lugano, 6900, Switzerland.
Bolis S; Lugano Cell Factory, Cardiocentro Ticino - Swiss Institute of Regenerative Medicine (SIRM), Via Tesserete 48, Lugano, 6900, Switzerland.
Lo Cicero V; Lugano Cell Factory, Cardiocentro Ticino - Swiss Institute of Regenerative Medicine (SIRM), Via Tesserete 48, Lugano, 6900, Switzerland.
Andriolo G; Lugano Cell Factory, Cardiocentro Ticino - Swiss Institute of Regenerative Medicine (SIRM), Via Tesserete 48, Lugano, 6900, Switzerland.
Turchetto L; Lugano Cell Factory, Cardiocentro Ticino - Swiss Institute of Regenerative Medicine (SIRM), Via Tesserete 48, Lugano, 6900, Switzerland. lucia.turchetto@cardiocentro.org.

Methods Mol Biol ; 1416: 339-56, 2016.

Article en En | MEDLINE | ID: mdl-27236682

ABSTRACT

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.

Asunto(s)

Endotoxinas/análisis; Células Madre Mesenquimatosas/citología; Control de Calidad; Bacterias/aislamiento & purificación; Recuento de Células; Técnicas de Cultivo de Célula/métodos; Supervivencia Celular; Células Cultivadas; Humanos; Inmunofenotipificación; Células Madre Mesenquimatosas/microbiología; Técnicas Microbiológicas; Mycoplasma/aislamiento & purificación

Palabras clave

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

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Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Control de Calidad / Endotoxinas / Células Madre Mesenquimatosas Límite: Humans Idioma: En Revista: Methods Mol Biol Asunto de la revista: BIOLOGIA MOLECULAR Año: 2016 Tipo del documento: Article País de afiliación: Suiza

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