The application of monoclonal antibody drugs in some disease treatment fields has been limited. In the treatment of tumors and autoimmune diseases, it is necessary to block multiple signal pathways to avoid compensatory effects. In addition, in viral infections, due to the high mutation rate of the virus, it is often necessary to combine multiple antigenic sites to prevent the escape of the virus. Therefore, bispecific antibodies (bsAbs) constructed by means of DNA recombination and protein engineering techniques have become one of the new research directions of antibody drugs.
BsAbs can simultaneously recognize and bind to two different antigens or epitopes. It can provide two effective sites of action, and can be flexibly designed for different drug targets to achieve the effect of multiple target therapy. BsAbs can effectively enhance the binding specificity and targeting of tumor cells and reduce side effects such as off-target due to their unique bifunctional structure and mechanism of action.
The activity, efficacy and immunogenicity of bsAbs are affected by their complex molecular structure and properties. In order to ensure the safety and effectiveness of bsAbs, in-depth characterization and quality monitoring of bsAbs are required to obtain approval for clinical trials and subsequent sales. The quality standards of the test mainly refer to the relevant technical guidelines of the International Conference on the Harmonization of Registered Drugs for Human Use (ICH), the Food and Drug Administration (FDA), the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP).
Creative Proteomics has advanced high-performance liquid chromatography, mass spectrometry and bioinformatics platforms. Based on rich experience and comprehensive characterization methods, we are able to support the verification of each bsAb product. We have developed a comprehensive method to determine the primary structure, high-level structure, post-translational modification, heterogeneity, etc. of bsAbs. We will strictly abide by various quality standards and can provide you with exclusive solutions to help you solve the problems and challenges you face.
Bispecific Antibody Characterization Service We Can Provide:
| The Category of Characterization Analysis | Items | Methods |
| Primary structure analysis | Complete molecular weight or reduction/desugar molecular weight detection | MALDI-TOF MS / ESI-TOF MS |
| N-terminal sequencing | LC-MS/MS | |
| C-terminal sequencing | LC-MS/MS | |
| Disulfide bond analysis | LC-MS/MS | |
| Sequence coverage analysis | LC-MS/MS | |
| Protein post-translational modification analysis | LC-MS/MS | |
| Glycosylation analysis | Glycosylation site analysis | LC-MS/MS |
| Glycotype analysis and content detection | LC-FLR-MS | |
| Binding activity analysis | Protein binding/inhibition analysis | ELISA（EC50，IC50） |
| Cell binding/inhibition analysis | FACS（EC50、IC50） | |
| Surface Plasmon Resonance (SPR) affinity assay | SPR | |
| Purity analysis | Monomer and polymer purity analysis | SEC-HPLC |
| Non-glycosylated heavy chain and small molecule fragments | SEC-HPLC / SDS-PAGE / CE-SDS | |
| Charge heterogeneity analysis | Charge isomer distribution | IEX-HPLC |
| Distribution of pI and different pI components | CE-IEF / cIEF | |
| Stability analysis | Determination of denaturation temperature | DSF |
Creative Proteomics is looking forward to cooperating with you. We will provide customized solutions. We are confident to provide you with technical support related to drug development, production process and other special requirements. If you have other questions, please feel free to contact us.
Related Sections
Antibody Drug Characterization Service
Monoclonal Antibody Characterization Service
Antibody Drug Conjugates (ADCs) Characterization Service
