Charge variant analysis is widely used in the characterization of monoclonal antibodies (mAbs). The analysis ensures products are in line with no unwanted changes to the protein. Increasing mAb drug products in the market requires robust charge variant analysis. Ion-exchange (IEX) analysis has been proven to be the gold standard method for the Quality Control (QC) characterization of charge variants.
Yaohai Bio-Pharma offers charge variant analysis based on Liquid Chromatography-Mass Spectrometry (LC-MS) / Ion-Exchange Chromatography-Mass Spectrometry (IEX-MS).
We have been involved in the Protein Structural Characterization of various large molecules, including Recombinant Subunit Vaccines, Nanobodies/VHHs/ Single-domain Antibodies (sdAbs), Antibody Fragments, Hormones/Peptides, Cytokines, Growth Factors (GF), Enzymes, Collagens, etc.
Regulatory Requirements for Charge Variant Analysis
United States Pharmacopeia (USP) states, “For biologics, charge variants have been identified as critical quality attributes (CQAs). There are multiple techniques i.e., IEX, capillary isoelectric focusing (cIEF)/ imaged capillary isoelectric focusing (icIEF) used for charge variant analysis.”
Analytical Method
| Analysis |
Methods |
| Charge Variant Analysis |
LC-MS, Liquid Chromatography-Mass Spectrometry
IEX-MS, Ion-Exchange Chromatography-Mass Spectrometry
|
Procedures
1. Dilution: The protein sample will be diluted to a certain concentration.
2. IEX-MS analyses: Protein with charge heterogeneity will be separated and detected using IEX-HPLC coupled with Mass Spectrometry (MS).
3. Data analysis
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