Creative Proteomics can provide you with the physical, chemical and structural characteristics, purity, impurities, content and other tests of antibody drug conjugates in strict accordance with various quality standards.
Antibody-Drug Conjugates (ADCs) are a new type of biopharmaceuticals that are conjugated with monoclonal antibodies and small molecule drugs with strong cytotoxicity through biologically active linkers. The mechanism of drug action is to specifically target the target cancer cells through monoclonal antibodies, and then to kill the cancer cells by coupled small molecule drugs. ADC combines the high specificity and targeting characteristics of monoclonal antibody drugs, as well as the high efficiency of small molecule drugs in removing cancer cells. It can synergize the advantages of antibody drugs and chemical drugs, and can reduce the damage to biological systems.
Compared with monoclonal antibodies, ADC has a complex structure and a high degree of heterogeneity, which brings great challenges to its structural characterization and characteristic analysis. Unconjugated naked antibodies, small molecules with cytotoxicity, and heterogeneity of conjugated drugs may affect the efficacy and safety of ADC drugs. Therefore, in order to ensure the safety and effectiveness of ADCs drugs, in-depth characterization and quality monitoring of ADCs drugs 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, high-throughput mass spectrometry and bioinformatics platforms. We have developed a set of integrated methods to determine the intact mass of antibody-drug conjugates, the intact mass of deglycosylation, the drug/antibody ratio, and the composition of polysaccharides. We will strictly follow the various quality standards and can provide you with exclusive solutions to help you solve the problems and challenges you face.
Antibody Drug Conjugates (ADCs) Characterization Service We Can Provide:
|Structural characterization of antibody drug conjugates||Amino acid sequence analysis|
|Peptide mapping analysis|
|Advanced structural analysis|
|Glycosylation and other protein post-translational modification analysis|
|Charge variants analysis|
|Size variants analysis|
|Drug-antibody coupling ratio (DAR) determination|
|Drug loading and distribution determination|
|Potency analysis||Target binding activity analysis|
|Biological activity analysis|
|Impurity analysis||Analysis of free drug content or ratio (residual naked antibody and small analytical drugs)|
|Analysis of impurities introduced in the production process|
MALDI-TOF mass spectrometry
ESI-TOF mass spectrometry
UV-MALDI mass spectrometry
Reversed-phase high performance liquid chromatography (RP-HPLC)
Hydrophilic interaction chromatography (HILIC)
Ion exchange chromatography (IEX)
Hydrophobic interaction chromatography (HIC)
Size exclusion chromatography column (SEC)
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.