Creative Proteomics can provide you with antibody drug characterization services. Detect, characterize and quantify impurities, as well as important parameters related to structural variants and modifications of the final product, affinity, stability, immunogenicity and safety.
With the constant discovery and neutralization of pathogens to help prevent disease, antibodies are an important part of our immune system. Since the US FDA first approved the use of antibodies in therapeutic drugs in the 1980s, antibody products, especially monoclonal antibodies (mAb), have become one of the main drivers of the growing biopharmaceutical market. Antibody drugs can be divided into murine monoclonal antibodies, human-mouse chimeric antibodies, humanized antibodies, and fully human antibodies.
1) Monoclonal antibody characterization
Monoclonal antibody drugs require in-depth characterization in order to obtain approval for clinical trials and subsequent marketing. The monoclonal antibody characterization should include determining the physical and chemical and structural properties, purity, impurities and other aspects of the mAb according to the International Harmonization Conference (ICH) guide Q6B (3).
2) Antibody drug conjugates (ADCs) characterization service
ADCs are composed of monoclonal antibodies and small molecule compounds. The antibody part of ADC specifically recognizes and binds to tumor cell surface antigens. Antibodies and small molecule compounds are brought into tumor cells together by endocytosis, releasing small molecule compounds. It can not only reduce the toxicity of small molecule drugs, but also has the effect of targeted binding. Compared with monoclonal antibodies, the production process of ADCs drugs is more complicated. Therefore, in order to ensure the safety and effectiveness of ADCs drugs, the quality of ADCs drugs needs to be monitored.
3) Bispecific antibody (bsAb) characterization
BsAbs are artificial antibodies with two specific antigen binding sites, which can simultaneously bind to two specific epitopes of the target protein. Currently, many types of bsAbs have been developed. The main types include trifunctional bsAbs, IgG-scFv, trivalent bispecific molecules, tandem single-chain antibodies (tandem scFv), DVD-Ig, and other forms. Compared with single antibodies, bsAbs have the advantages of high specificity, strong targeting, high yield, good stability, less dosage, and less toxic and side effects. The molecular structure and properties of bsAb may be more complex, so it is necessary to evaluate all expected properties according to ICH guidelines and strictly control critical quality attributes (CQA).
Antibody Drug Characterization Services We Can Provide:
|Antibody Primary Structure Analysis||Molecular Weight Determination of Intact Antibody Drugs|
|Antibody N-Terminal Sequencing|
|Antibody C-Terminal Sequencing|
|Antibody Amino Acid Analysis|
|Antibody Advanced Structure Analysis||Secondary Structure|
|Antibody Modification Analysis||Glycosylation Analysis|
|Deamidation and Oxidation analysis|
|Disulfide Bridges & Free Sulfhydryl Groups Analysis|
|C-terminal Lysine Variants Determination|
|Impurity Analysis||Purity Analysis|
|Charge Heterogeneity Analysis|
|Analysis of Residual Protein A in Host Cells|
|Analysis of Foreign DNA Residues|
|Other Service||Mass Spectrometry based Epitope Mapping|
|Surface Plasmon Resonance (SPR) Service|
Creative Proteomics will strictly comply with FDA and ICH guidelines to provide you with comprehensive antibody-related analysis services. We will tailor a one-stop solution for you. We are confident to provide you with technical support for drug discovery, manufacturing process and other special requirements. Looking forward to cooperating with you. If you have any other questions, please feel free to contact us.