Predictive Nature of High-Throughput Assays in ADC Formulation Screening.
Antibody-drug conjugates
Developability screening
High-throughput technology
Physical stability
Preformulation
Protein aggregation
Protein formulation
Journal
Journal of pharmaceutical sciences
ISSN: 1520-6017
Titre abrégé: J Pharm Sci
Pays: United States
ID NLM: 2985195R
Informations de publication
Date de publication:
07 2023
07 2023
Historique:
received:
19
12
2022
revised:
28
03
2023
accepted:
29
03
2023
medline:
19
6
2023
pubmed:
11
4
2023
entrez:
10
4
2023
Statut:
ppublish
Résumé
Utilization of high-throughput biophysical screening techniques during early screening studies is warranted due to the limited amount of material and large number of samples. But the predictability of the data to longer-term storage stability is critical as the high-throughput methods assist in defining the design space for the longer-term studies. In this study, the biophysical properties of two ADCs in 16 formulation conditions were evaluated using high-throughput techniques. Conformational stability and colloidal stability were evaluated by determining T
Identifiants
pubmed: 37037342
pii: S0022-3549(23)00141-7
doi: 10.1016/j.xphs.2023.03.021
pii:
doi:
Substances chimiques
Antibodies, Monoclonal
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1821-1831Informations de copyright
Copyright © 2023 American Pharmacists Association. Published by Elsevier Inc. 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.