Characteristics of Glycan in Biotherapeutic Monoclonal Antibodies Marketed in Thailand
Keywords:
Glycan, CE-LIF, Monoclonal antibodyAbstract
Characterization of the structure and composition of glycan in biotherapeutic monoclonal antibodies (mAb) is essential for drug development and quality control. If the production process is not consistently controlled, there is a possibility to obtain mAb with different forms of glycan (glycoforms). The different glycoforms may alter the quality and safety of mAb as well as affect drug efficacy. Therefore, characterization of glycan in 12 brands of mAb registered in Thailand during 2014 - 2016 was performed with capillary electrophoresis using laser-induced fluorescence (CE-LIF) method. The results of LIF detection of 9-aminopyrene - 1, 4, 6-trisulfonic acid labeled on glycan after digestion of mAb with PNGase F showed that mAb complied with their reference materials as well as USP glycan standards. All 12 brands of mAb consisted of four major types of glycoforms: G0F, G1Fa, G1Fb and G2F which complied with their registration. Glycan type G0F had the highest amount in the range of 39.30 - 85.29 % and migration time detected by CE-LIF was within 9.41 - 9.65 minutes.
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