An antibody evaluation detection method and its application in antibody developability evaluation
Through high pH pressure treatment and SEC-HPLC, iCIEF, SPR/FACS detection technology, the problem of monoclonal antibody deamidation evaluation is solved, and the rapid and accurate antibody developmentability evaluation is achieved, which reduces detection cost and time and ensures the antibody safety and effectiveness.
Patent Information
- Application Number
- CN202211102619.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2022-09-09
- Publication Date
- 2025-01-07
- Estimated Expiration
- 2042-09-09
AI Technical Summary
The prior art is difficult to quickly and reliably evaluate the deamidation of monoclonal antibodies, resulting in loss of antibody activity and increased immunogenicity, affecting the safety and effectiveness of drugs, and the existing detection methods such as mass spectrometry and peptide mapping analysis take time. And it is expensive and does not apply to the developmentability assessment of initial antibodies.
Using high pH pressure treatment and deamidation product detection methods, the purity and charge heterogeneity of antibodies are detected by SEC-HPLC and iCIEF, and the antibody activity is detected in combination with SPR or FACS, which simulates the deamidation of antibodies during transportation, and accelerates the evaluation process. , provides an easy-to-operate and time-saving detection method.
It achieves rapid and accurate evaluation of the degree and activity of the antibody, reduces the detection cost and time, and is suitable for the developmentability assessment of the initial antibodies, ensuring the safety and effectiveness of the antibody.