Anti-AAV6 antibody and application thereof in AAV6 titer determination

By developing the Anti-AAV6 monoclonal antibody 3G8 and designing a double-antibody sandwich ELISA kit, the challenge of AAV6 vector titer determination was solved, achieving highly specific and accurate titer determination, and improving the quality control and safety of gene therapy drugs.

CN121045368APending Publication Date: 2025-12-02KAIKA BIOTECHNOLOGY (SHANGHAI) CO LTD
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Patent Information

Application Number
CN202511316604.1
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-09-16
Publication Date
2025-12-02

AI Technical Summary

Technical Problem

The lack of highly specific AAV6 antibodies and reliable quantitative methods in existing technologies makes it difficult to determine the titer of AAV6 vectors, which affects the research and development and quality control of gene therapy drugs.

Method used

A highly specific anti-AAV6 monoclonal antibody, 3G8, was developed, and a double-antibody sandwich ELISA kit was designed based on this antibody for the specific capture and detection of AAV6 viral particles, enabling accurate titer determination.

Benefits of technology

It achieves highly specific identification and accurate quantification of AAV6 viral particles, reduces the risk of false positives, provides highly precise and repeatable titer determination results, and ensures the safety and efficacy of gene therapy drugs.

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Abstract

The invention belongs to the technical field of biology, and relates to an anti-AAV6 antibody and application thereof in AAV6 titer determination. The anti-AAV6 monoclonal antibody 3G8 with high specificity is obtained through mouse immunization and antibody screening, and the antibody can specifically recognize and combine with complete AAV6 virus particles or carrier particles. The mouse Anti-AAV6 monoclonal antibody 3G8 has high serotype specificity, is only combined with AAV6 complete virus particles, and does not react with virus particles of other serotypes such as AAV2, AAV5, AAV8, AAV9 and the like. Meanwhile, conformational epitope dependency is achieved, only the native conformational epitope of the AAV6 capsid is recognized, and VP1 subunits, VP2 subunits and VP3 subunits in a depolymerization state are not combined.
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