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Article

Assessing the Manufacturability and Critical Quality Attribute Profiles of Anti-IL-8 Immunoglobulin G Mutant Variants.

Molecular pharmaceutics - 2 Dec 2024

Armstrong Georgina Bethany, Burley Glenn A, Lewis William, Rattray Zahra

Abstract excerpt

Early-phase manufacturability assessment of high-concentration therapeutic monoclonal antibodies (mAbs) involves screening of process-related risks impacting their translation into the clinic. Manufacturing a mAb at scale relies on cost-effective and robust approaches to derisk manufacturability parameters, such as viscosity, conformational stability, aggregation, and process-related impurities. Using a panel of...

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Methodology Data sources Editorial policy Privacy About Contact Helena Bioinformatics

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Identifiers

PMID: 39509699
DOI: 10.1021/acs.molpharmaceut.4c01010
PMCID: PMC11615950

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