Enabling adoption of 2D-NMR for the higher order structure assessment of monoclonal antibody therapeutics.
NISTmAb
chemometrics
comparability
higher order structure
monoclonal antibody (mAb) therapeutics
nuclear magnetic resonance spectroscopy (NMR)
Journal
mAbs
ISSN: 1942-0870
Titre abrégé: MAbs
Pays: United States
ID NLM: 101479829
Informations de publication
Date de publication:
01 2019
01 2019
Historique:
pubmed:
21
12
2018
medline:
16
7
2019
entrez:
21
12
2018
Statut:
ppublish
Résumé
The increased interest in using monoclonal antibodies (mAbs) as a platform for biopharmaceuticals has led to the need for new analytical techniques that can precisely assess physicochemical properties of these large and very complex drugs for the purpose of correctly identifying quality attributes (QA). One QA, higher order structure (HOS), is unique to biopharmaceuticals and essential for establishing consistency in biopharmaceutical manufacturing, detecting process-related variations from manufacturing changes and establishing comparability between biologic products. To address this measurement challenge, two-dimensional nuclear magnetic resonance spectroscopy (2D-NMR) methods were introduced that allow for the precise atomic-level comparison of the HOS between two proteins, including mAbs. Here, an inter-laboratory comparison involving 26 industrial, government and academic laboratories worldwide was performed as a benchmark using the NISTmAb, from the National Institute of Standards and Technology (NIST), to facilitate the translation of the 2D-NMR method into routine use for biopharmaceutical product development. Two-dimensional
Identifiants
pubmed: 30570405
doi: 10.1080/19420862.2018.1544454
pmc: PMC6343768
doi:
Substances chimiques
Antibodies, Monoclonal
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
94-105Références
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