Biosorption of process-equipment-related leachables (PERLs) in biomanufacturing: A quantitative approach to study partitioning of PERLs in a cell culture system.
CAR-T Manufacturing
Cell Culture
Extractables and Leachables
Partitioning
Single-Use Systems
Journal
International journal of pharmaceutics
ISSN: 1873-3476
Titre abrégé: Int J Pharm
Pays: Netherlands
ID NLM: 7804127
Informations de publication
Date de publication:
25 Mar 2023
25 Mar 2023
Historique:
received:
11
11
2022
revised:
11
02
2023
accepted:
14
02
2023
pubmed:
23
2
2023
medline:
21
3
2023
entrez:
22
2
2023
Statut:
ppublish
Résumé
The assessment and potential risk of process equipment-related leachables (PERLs) in the production of biopharmaceuticals and cell therapeutics using single-use (SU) equipment has been discussed previously. However, potential interactions of cells with PERLs have not yet been considered. Here, we present a quantitative adsorption study of neutral, organic small-molecule leachable compounds - known for extractables & leachables (E&L) analysis of SU equipment - in aqueous suspensions of CHO and T cells. The solid-water partition coefficient K
Identifiants
pubmed: 36804518
pii: S0378-5173(23)00162-X
doi: 10.1016/j.ijpharm.2023.122742
pii:
doi:
Substances chimiques
Organic Chemicals
0
Water
059QF0KO0R
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
122742Informations de copyright
Copyright © 2023 Elsevier B.V. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.