Complete intra-laboratory validation of a LAL assay for bacterial endotoxin determination in EBV-specific cytotoxic T lymphocytes

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Endotoxin content is a critical factor that affects the safety of biological pharmaceutical products. International pharmacopoeias describe several reference methods to determine endotoxin levels in advanced therapy medicinal product (ATMP) preparations. Administration of ATMPs must be done as rapid...

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Detalles Bibliográficos
Autores principales: Pasqua, Salvatore, Niotta, Maria Concetta, Di Martino, Giuseppina, Sottile, Davide, Douradinha, Bruno, Miele, Monica, Timoneri, Francesca, Di Bella, Mariangela, Cuscino, Nicola, Di Bartolo, Chiara, Conaldi, Pier Giulio, D’Apolito, Danilo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Society of Gene & Cell Therapy 2021
Materias:
Original Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8408548/
https://www.ncbi.nlm.nih.gov/pubmed/34514024
http://dx.doi.org/10.1016/j.omtm.2021.05.002

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