Rational optimization of a monoclonal antibody improves the aggregation propensity and enhances the CMC properties along the entire pharmaceutical process chain.
In silico
CMC properties
antibody engineering
bioinformatic
biotherapeutic development
pharmaceutical industry
Journal
mAbs
ISSN: 1942-0870
Titre abrégé: MAbs
Pays: United States
ID NLM: 101479829
Informations de publication
Date de publication:
Historique:
entrez:
14
7
2020
pubmed:
14
7
2020
medline:
6
7
2021
Statut:
ppublish
Résumé
The discovery of therapeutic monoclonal antibodies (mAbs) primarily focuses on their biological activity favoring the selection of highly potent drug candidates. These candidates, however, may have physical or chemical attributes that lead to unfavorable chemistry, manufacturing, and control (CMC) properties, such as low product titers, conformational and colloidal instabilities, or poor solubility, which can hamper or even prevent development and manufacturing. Hence, there is an urgent need to consider the developability of mAb candidates during lead identification and optimization. This work provides a comprehensive proof of concept study for the significantly improved developability of a mAb variant that was optimized with the help of sophisticated
Identifiants
pubmed: 32658605
doi: 10.1080/19420862.2020.1787121
pmc: PMC7531517
doi:
Substances chimiques
Antibodies, Monoclonal
0
Protein Aggregates
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Video-Audio Media
Langues
eng
Sous-ensembles de citation
IM
Pagination
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