Detection method of antibody-drug conjugate

By using non-porous polystyrene-divinylbenzene fillers and gradient elution procedures in high performance liquid chromatography, combined with phenyl hydrophobic fillers, the problem of difficult separation of antibody-drug conjugates with different DAR values ​​in the prior art is solved, and the separation effect of high efficiency, selectivity and resolution is achieved, providing an effective method for the detection and preparation of ADC drugs.

CN119715850APending Publication Date: 2025-03-28SUZHOU SEPAX TECHNOLOGIES INC
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Patent Information

Application Number
CN202411899289.5
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-12-23
Publication Date
2025-03-28

AI Technical Summary

Technical Problem

It is difficult to effectively isolate antibody-drug conjugates of different DAR values ​​in the prior art, and the existing chromatographic fillers have limited separation ability on ADCs, making it difficult to take into account separation efficiency, selectivity and resolution.

Method used

Using high performance liquid chromatography, a chromatography column with non-porous polystyrene-divinylbenzene as filler was used. By optimizing the volume fraction and gradient elution program of the mobile phase, combined with a specially designed phenyl hydrophobic filler, the separation ability of ADCs of different DAR values ​​was significantly improved.

Benefits of technology

It realizes effective separation of ADC components of multiple DAR values, taking into account separation efficiency, selectivity and resolution, and is suitable for qualitative and quantitative detection of ADC drugs, providing an effective strategy for the preparation process and finished product quality control.

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Abstract

The invention discloses a detection method of an antibody-drug conjugate, wherein an antibody part is IgG1 with the molecular weight of 145KDa, a drug part is monomethyl auristatin E, and a connecting fragment is Val-Cit. According to the method, the ADC components with multiple DAR values can be effectively separated by optimizing the chromatographic column filler and the mobile phase system, the separation efficiency, selectivity and resolution of ADC detection are considered, the method can be used for qualitative and quantitative detection, and an effective strategy is provided for the preparation process of ADC drugs and quality control of finished product release.
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