Method Development and Qualification of pH-Based CEX UPLC Method for Monoclonal Antibodies

Post-translational modifications (“PTMs”) in monoclonal antibodies (mAbs) contribute to charge variant distribution, which will affect biological efficacy and safety. For the characterization of mAbs, charge variants are used as a critical quality attributes for product quality, stability consistenc...

Full description

Bibliographic Details
Main Authors: Mithun Bhatt, Anshu Alok, Bhushan B. Kulkarni
Format: Article
Language:English
Published: MDPI AG 2022-06-01
Series:BioTech
Subjects:
Online Access:https://www.mdpi.com/2673-6284/11/2/19