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Validation of analytical methods in compliance with good manufacturing practice: a practical approach

BACKGROUND: The quality and safety of cell therapy products must be maintained throughout their production and quality control cycle, ensuring their final use in the patient. We validated the Lymulus Amebocyte Lysate (LAL) test and immunophenotype according to International Conference on Harmonizati...

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Detalles Bibliográficos
Autores principales:	Rustichelli, Deborah, Castiglia, Sara, Gunetti, Monica, Mareschi, Katia, Signorino, Elena, Muraro, Michela, Castello, Laura, Sanavio, Fiorella, Leone, Marco, Ferrero, Ivana, Fagioli, Franca
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BioMed Central 2013
Materias:	Methodology
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3765465/ https://www.ncbi.nlm.nih.gov/pubmed/23981284 http://dx.doi.org/10.1186/1479-5876-11-197

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