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

• Päätekijät: Alessandro Ascione (Tekijä), Marcello Belfiore (Tekijä), Jaana Vesterinen (Tekijä), Mihaela Buda (Tekijä), Wolf Holtkamp (Tekijä), Francesca Luciani (Tekijä)
• Aineistotyyppi: Kirja
• Julkaistu: Taylor & Francis Group, 2024-12-01T00:00:00Z.
• Aiheet: article
• Linkit: 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...