Chapter title |
Quality Control Assays for Clinical-Grade Human Mesenchymal Stromal Cells: Validation Strategy.
|
---|---|
Chapter number | 20 |
Book title |
Mesenchymal Stem Cells
|
Published in |
Methods in molecular biology, January 2016
|
DOI | 10.1007/978-1-4939-3584-0_20 |
Pubmed ID | |
Book ISBNs |
978-1-4939-3582-6, 978-1-4939-3584-0
|
Authors |
Marina Radrizzani, Sabrina Soncin, Sara Bolis, Viviana Lo Cicero, Gabriella Andriolo, Lucia Turchetto |
Editors |
Massimiliano Gnecchi |
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. |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 28 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
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Researcher | 6 | 21% |
Student > Ph. D. Student | 5 | 18% |
Student > Master | 4 | 14% |
Student > Bachelor | 2 | 7% |
Other | 2 | 7% |
Other | 2 | 7% |
Unknown | 7 | 25% |
Readers by discipline | Count | As % |
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Agricultural and Biological Sciences | 5 | 18% |
Biochemistry, Genetics and Molecular Biology | 4 | 14% |
Engineering | 4 | 14% |
Pharmacology, Toxicology and Pharmaceutical Science | 2 | 7% |
Medicine and Dentistry | 2 | 7% |
Other | 3 | 11% |
Unknown | 8 | 29% |