Imaging capillary isoelectric focusing for detection of mispaired byproducts in asymmetric bispecific antibodies
By utilizing the imaging capillary isoelectric focusing (iCIEF) method, the significant pI difference between the half-antibodies of asymmetric bispecific antibodies is used to separate and quantify mismatched byproducts, solving the problem of difficult detection and quantification in existing technologies, and improving the purification efficiency of BsAb and the quality of drug products.
Patent Information
- Application Number
- CN202580010888.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2024-01-23
- Filing Date
- 2025-01-22
- Publication Date
- 2026-08-28
AI Technical Summary
Existing technologies lack standardized analytical methods to accurately identify and quantify mismatch byproducts in asymmetric bispecific antibodies, especially since homodimers and heterodimers lack differences in physicochemical properties, leading to difficulties in separation and detection.
Imaging capillary isoelectric focusing (iCIEF) was employed to utilize the significant pI difference between half-antibodies of asymmetric bispecific antibodies (AsBsAb). Mismatch byproducts, particularly half-antibodies containing chimeric and non-chimeric Fabs, were separated and detected by capillary isoelectric focusing. The mortise and tenon (KiH) structure was used to promote heterodimerization.
This method enables efficient separation and quantification of asymmetric BsAb mismatch byproducts, improves heterodimer purification efficiency, provides a reliable analytical method, and ensures the homogeneity and safety of drug products.