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KMID : 1142220220170010027
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Regulatory Research on Food, Drug & Cosmetic
2022 Volume.17 No. 1 p.27 ~ p.36
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Comparative Study on Charge Variant Analytical Methods of CEX-HPLC and cIEF for the Monoclonal Antibody Drug
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Son Ae-Ra
Kim Hyun-Ju
Hong Young-Ki
An Gwang-Jin
Oh Ho-Kyung
Woo Jeong-Nam
Kang So-Yeong
Eom Joon-Ho
Park Ki-Dae
Park Mi-Sun
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Abstract
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The domestic and foreign biopharmaceutical markets are rapidly growing every year, and the monoclonal antibody (mAb) drugs have become a predominant treatment modality for various diseases, including cancer and autoimmune disease. Accordingly, various analysis technologies are being developed to evaluate the quality of biopharmaceuticals more accurately and efficiently. It has been reported that the accumulation of charge variants of mAb during the manufacturing process and storage can affect the efficacy and stability of the mAb drug. However, proper analytical methods for assessing mAb charge variants remain to be verified. In this study, we compared two methods (CEX-HPLC and cIEF) which are frequently used to measure the charge variants of anti- TNF-α mAb drugs for quality control. We compared and investigated based on the review data related to the quality of mAb drugs approved in Korea. The applicability of the charge variant analytical methods was verified according to the ICH guideline Q2(R1) and the KFDA’s ‘Validation Guidelines’ - specificity, precision, accuracy, linearity, range, and detection limits. As results, the accuracy of the CEX-HPLC and cIEF was 97~102% and 91~112%, respectively with high linearity (R2 > 0.98). The repeatability test for the methods resulted in a low %RSD (<1.3% for CEX-HPLC, 2.6% for cIEF). Here, we demonstrated that both analytical methods can measure the charge variant of a monoclonal antibody, and each analytical method can show different charge variant patterns. Taken together, we suggest that the proper selection of an analytical method for mAb charge variants is important to assure the stability and quality of mAb drugs. This study would contribute to improving the quality control and the life-cycle safety management of mAb drugs.
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KEYWORD
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Monoclonal antibody drugs, Charge variants, Analytical methods, Quality control
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