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Updated: Mar 20, 2026
Human Mesenchymal Stem Cell Processing for Clinical Applications Using a Closed Semi-Automated Workflow
Published on: March 17, 2023
Quality Control Assays for Clinical-Grade Human Mesenchymal Stromal Cells: Validation Strategy
Marina Radrizzani1, Sabrina Soncin1, Sara Bolis1
1Lugano Cell Factory, Cardiocentro Ticino - Swiss Institute of Regenerative Medicine (SIRM), Via Tesserete 48, Lugano, 6900, Switzerland.
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.
