Charge heterogeneity of therapeutic monoclonal antibodies by different cIEF systems: views on the current situation

Charge heterogeneity of therapeutic monoclonal antibodies by different cIEF systems: views on the current situation

Therapeutic mAbs show a specific “charge fingerprint” that may affect safety and efficacy, and, as such, it is often identified as a critical quality attribute (CQA). Capillary iso-electric focusing (cIEF), commonly used for the evaluation of such CQA, provides an analytical tool to investigate mAb...

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Bibliographic Details
Main Authors: Alessandro Ascione, Marcello Belfiore, Jaana Vesterinen, Mihaela Buda, Wolf Holtkamp, Francesca Luciani
Format: Article
Language:English
Published: Taylor & Francis Group 2024-12-01
Series:mAbs
Subjects:
Charge heterogeneity profile
cIEF
identity
isoelectric point
purity
quality control
Online Access:https://www.tandfonline.com/doi/10.1080/19420862.2024.2313737
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