Nano differential scanning fluorimetry for comparability studies of therapeutic proteins.
Biosimilarity
Comparability
Higher order structure
Therapeutic proteins
nanoDSF
Journal
Analytical biochemistry
ISSN: 1096-0309
Titre abrégé: Anal Biochem
Pays: United States
ID NLM: 0370535
Informations de publication
Date de publication:
15 03 2020
15 03 2020
Historique:
received:
11
10
2019
revised:
07
01
2020
accepted:
10
01
2020
pubmed:
15
1
2020
medline:
13
1
2021
entrez:
15
1
2020
Statut:
ppublish
Résumé
Differential scanning calorimetry (DSC) has been extensively used in the biopharmaceutical industry to characterize protein thermal stability and domain folding integrity. Recently, nano differential scanning fluorimetry (nanoDSF) has emerged as a powerful tool for thermal stability analysis and studies of protein domain unfolding. Due to increased interests in the qualification of characterization methods, we are in this study presenting the qualification results for the comparability studies of thermal stability analysis using nanoDSF. The results show that nanoDSF is able to detect thermal transition signals for mAbs, BiTE® molecules, and cytokines at a wide concentration range with high precision, clearly indicating that nanoDSF is suitable for characterization including comparability studies of therapeutic proteins. Compared to the current recognized industry standard DSC, the nanoDSF method enables thermal stability analysis over a much wider concentration range, consumes considerably less materials, and provides significantly higher throughput.
Identifiants
pubmed: 31935356
pii: S0003-2697(19)31005-X
doi: 10.1016/j.ab.2020.113581
pii:
doi:
Substances chimiques
Antibodies, Monoclonal
0
Cytokines
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
113581Informations de copyright
Copyright © 2020 Elsevier Inc. All rights reserved.