Variations in critical quality attributes (CQAs) on therapeutic monoclonal antibodies (mAbs) due to cultivation conditions, storage conditions and external stress-factors
Ensuring close control of critical quality attributes (CQAs), such as post-translational modifications (PTMs), in therapeutic monoclonal antibodies (mAbs) is essential for maintaining function and batch homogeneity in large-scale production. Common PTMs include deamidation, fragmentation, oxidation, charge variants, and glycosylations. This study aimed to evaluate CQA variations and correlate the
