Improved Diffusion Interaction Parameter Measurement to Predict the Viscosity of Concentrated mAb Solutions.

diffusion interaction parameter high concentration formulation protein−protein interactions viscosity

Journal

Molecular pharmaceutics
ISSN: 1543-8392
Titre abrégé: Mol Pharm
Pays: United States
ID NLM: 101197791

Informations de publication

Date de publication:
04 Dec 2023
Historique:
medline: 5 12 2023
pubmed: 31 10 2023
entrez: 31 10 2023
Statut: ppublish

Résumé

During the developability assessment of therapeutic monoclonal antibody (mAb) candidates, utilization of robust high-throughput predictive assays enables rapid selection of top candidates with low risks for late-stage development. Predicting the viscosities of highly concentrated mAbs using limited materials is an important aspect of developability assessment because high viscosity can complicate manufacturability, stability, and administration. Here, we report a high-throughput assay measuring protein-protein interactions to predict mAb viscosity. The diffusion interaction parameter (

Identifiants

pubmed: 37906640
doi: 10.1021/acs.molpharmaceut.3c00797
doi:

Substances chimiques

Antibodies, Monoclonal 0
Sodium Chloride 451W47IQ8X
Solutions 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

6420-6428

Auteurs

Yangjie Wei (Y)

Drug Product Technologies, Amgen Inc., 1 Amgen Center Drive, Thousand Oaks, California 91320, United States.

Wei Qi (W)

Drug Product Technologies, Amgen Inc., 1 Amgen Center Drive, Thousand Oaks, California 91320, United States.

Erick Maglalang (E)

Drug Product Technologies, Amgen Inc., 1 Amgen Center Drive, Thousand Oaks, California 91320, United States.

Emma M Pelegri-O'Day (EM)

Molecular Analytics, Biologics Therapeutics Discovery, Amgen Inc., 1 Amgen Center Drive, Thousand Oaks, California 91320, United States.

Michelle Luong (M)

Drug Product Technologies, Amgen Inc., 1 Amgen Center Drive, Thousand Oaks, California 91320, United States.

Vladimir Razinkov (V)

Drug Product Technologies, Amgen Inc., 1 Amgen Center Drive, Thousand Oaks, California 91320, United States.

Christopher Sloey (C)

Drug Product Technologies, Amgen Inc., 1 Amgen Center Drive, Thousand Oaks, California 91320, United States.

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Classifications MeSH