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

• Main Authors: Alessandro Ascione (Author), Marcello Belfiore (Author), Jaana Vesterinen (Author), Mihaela Buda (Author), Wolf Holtkamp (Author), Francesca Luciani (Author)
• Format: Book
• Published: Taylor & Francis Group, 2024-12-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

ABSTRACTTherapeutic 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 t...