Charge variant analysis of trastuzumab (SP-FT 4A)

Antibody drugs are produced from animal cells, and modification of proteins after their translation may result in variation of product’s uniformity. Consistent uniformity is important for the quality of biopharmaceuticals. Since uniformity variation can influence the functionalities of produced drugs, various quality assessments are required. One of them is charge variant analysis (charge isomer). In this application note, Showa Denko discusses a unique charge variant analysis method using an ion exchange column (IEC SP-FT 4A).