Monoclonal antibody for detecting varicella-zoster virus glycoprotein e and use thereof

The double-antibody sandwich ELISA method for detecting recombinant varicella-zoster virus glycoprotein E solves the problem of lack of sensitive and accurate quantitative detection of gE antigen in existing technologies, achieving high sensitivity and high accuracy detection results, and is suitable for quality control and infection diagnosis of VZV vaccine.

CN122234191APending Publication Date: 2026-06-19CHENGDU OLYMVAX BIOPHARM +1
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
CHENGDU OLYMVAX BIOPHARM
Filing Date
2026-02-06
Publication Date
2026-06-19

AI Technical Summary

Technical Problem

The existing recombinant varicella-zoster virus vaccine production process lacks a sensitive, accurate, and specific method for quantitative detection of gE antigen, making it difficult to meet the quality control requirements of vaccine production.

Method used

A double-antibody sandwich assay was employed to detect recombinant varicella-zoster virus glycoprotein E using IgG monoclonal antibodies mAb 1 and mAb 2. Antibodies were prepared using CHO cells, SP2/0 cells, NSO cells, or HEK293 cells. mAb 2 was then labeled with horseradish peroxidase to generate a sandwich combination of capture antibody-antigen-detection antibody for ELISA detection.

Benefits of technology

It achieves highly sensitive detection (4.38 pg/ml) of gE protein in VZV vaccine, with good linear range, precision and accuracy, meeting the quality control requirements of vaccine industrial production. It also has strong thermal stability and is suitable for the evaluation of VZV vaccine and infection diagnosis.

✦ Generated by Eureka AI based on patent content.

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Abstract

This invention relates to monoclonal antibodies for detecting varicella-zoster virus glycoprotein E and their applications. The invention comprises two mouse-derived Fc regions, mAb 1 and mAb 2. The amino acid sequence of the light chain variable region (VL) of monoclonal antibody mAb 1 is shown in SEQ ID NO.1, and the amino acid sequence of the heavy chain variable region (VH) is shown in SEQ ID NO.2. The amino acid sequence of the light chain variable region (VL) of monoclonal antibody mAb 2 is shown in SEQ ID NO.3, and the amino acid sequence of the heavy chain variable region (VH) is shown in SEQ ID NO.4. The amino acid sequence of the gE protein used is shown in SEQ ID NO.5. This invention provides a sensitive, accurate, broad-range, and specific method for the quantitative detection of gE antigen and the determination of vaccine bulk in the VZV vaccine production process.
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