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KMID : 0390320120220020001
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Chungbuk Medical Journal
2012 Volume.22 No. 2 p.1 ~ p.15
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Development of a Bioanalytical Method of Therapeutic Monoclonal Antibody against EGFR
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Kim Kyung-Yong
Kim Seung-Ryul
Jang Hae-Lan
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Abstract
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Purpose: Few reports on the development and validations of bioanalytical methods for Pharmacokinetics (PK) studies have been reported. In this paper, a test method to quantify the antibody from a biological sample was developed with humanized monoclonal antibody (X01 Mab) against a clinically validated Epidermal Growth Factor (EGF) receptor.
Materials and Methods: The purified EGFR ECD proteins were then used to develop a Sandwich ELISA method which was validated to check whether the method could meet the guidelines of US FDA and EMA and the recommendations suggested at AAPS (American associated pharmaceutical scientist) and US FDA-organized workshop. Clinical usefulness of the X01 ELISA method was evaluated by using in PK study at cynomolgus monkey.
Results: The recombinant ECD was used as capture and detector at a Sandwich ELISA (X01ELISA) to increase its sensitivity through Biotin/Avidin-HRP method. In addition, according torecent, international guidelines, test methods were validated. X01 ELISA have high sensitivity of (LLOQ: 7.8 ng/㎖) and wide quantitative range of 7.8 ng/㎖-500 ng/㎖ at plasma. PK study of X01 MAb conducted with Cynomolgus monkey shows that the exact quantification of X01 in the
biological samples was possible when the monkey was injected with the high concentration of 7.8㎎/kg of the antibody.
Conclusion: Taken together, these results demonstrated that our ELISA method could be useful to
study clinical tests for therapeutic antibodies.
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KEYWORD
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Therapeutic Monoclonal Antibody, Pharmacokinetics Study, Epidermal Growth Factor Receptor
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