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

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

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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Bibliographic Details
Main Authors: Salvatore Pasqua, Maria Concetta Niotta, Giuseppina Di Martino, Davide Sottile, Bruno Douradinha, Monica Miele, Francesca Timoneri, Mariangela Di Bella, Nicola Cuscino, Chiara Di Bartolo, Pier Giulio Conaldi, Danilo D’Apolito
Format: Article
Language:English
Published: Elsevier 2021-09-01
Series:Molecular Therapy: Methods & Clinical Development
Subjects:
advanced therapy medicinal products
ATMPs
endotoxins
qualification
method validation
Limulus amebocyte lysate
Online Access:http://www.sciencedirect.com/science/article/pii/S2329050121000863

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http://www.sciencedirect.com/science/article/pii/S2329050121000863

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