Charge Variants Analysis of Biotherapeutic Monoclonal Antibody by Capillary Isoelectric Focusing
Keywords:
monoclonal antibodies, charge variants, biosimilars, capillary isoelectric focusingAbstract
Monoclonal antibody molecules of therapeutic finished products could have variations due to their charge variants. Changes of charge profile could alter drug stability, bioactivity and/or induce harmful immunogenicity. Therefore, each batch should contain a consistent charge variant profile. This study was conducted to analyse charge heterogeneity of 14 brands of therapeutic monoclonal antibodies registered in Thailand using cIEF technique. The electropherogram results of all products showed 3 isoforms and complied with their reference material isoforms. Their pI range was within 7 - 10, while pI ranges of basic and acidic variants were 9.48 - 6.70 and 9.24 - 6.40, respectively. In addition, reference product showed better stability than its biosimilars when compared to their isoforms after incubation at 37 °C for 5 days. In conclusion, the therapeutic monoclonal antibodies registered in Thailand contained charge variants according to their reference materials; however, quality monitoring of lots of those therapeutic monoclonal antibody drug products should be considered including stability of biosimilars.
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ประกาศสำนักงานคณะกรรมการอาหารและยา เรื่อง เอกสารหลักฐานการขอขึ้นทะเบียนตำรับยาชีววัตถุคล้ายคลึง. ราชกิจจานุเบกษา เล่มที่ 130 ตอนพิเศษ 174 ง (ลงวันที่ 4 ธันวาคม 2556).
