| Autor: |
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 |
| Jazyk: |
angličtina |
| Rok vydání: |
2021 |
| Předmět: |
|
| Zdroj: |
Molecular Therapy: Methods & Clinical Development, Vol 22, Iss , Pp 320-329 (2021) |
| Druh dokumentu: |
article |
| ISSN: |
2329-0501 |
| DOI: |
10.1016/j.omtm.2021.05.002 |
| Popis: |
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 rapidly as possible to ensure complete viability and potency of the cellular product. To evaluate the endotoxin content in the shortest time possible, we chose to validate an alternative method based on the use of the Charles River Portable Testing System (PTS) and FDA-approved cartridges, compliant with the requirements of the European Pharmacopoeia and providing results in |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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