A practical approach for the validation of sterility, endotoxin and potency testing of bone marrow mononucleated cells used in cardiac regeneration in compliance with good manufacturing practice

BACKGROUND: Main scope of the EU and FDA regulations is to establish a classification criterion for advanced therapy medicinal products (ATMP). Regulations require that ATMPs must be prepared under good manufacturing practice (GMP). We have validated a commercial system for the determination of bact...

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Detalles Bibliográficos
Autores principales: Soncin, Sabrina, Lo Cicero, Viviana, Astori, Giuseppe, Soldati, Gianni, Gola, Mauro, Sürder, Daniel, Moccetti, Tiziano
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2009
Materias:
Methodology
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2753319/
https://www.ncbi.nlm.nih.gov/pubmed/19737416
http://dx.doi.org/10.1186/1479-5876-7-78

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