Antibody drug homogeneity analysis mainly includes identification and consistency analysis, purity and impurities (molecular size variants, charge variants, product-related impurities and process-related impurities).
Size heterogeneity is one of the important quality control indicators of antibody drugs. Size heterogeneity can generally be divided into three categories, namely monomer, fragment and aggregate forms. In the case of monoclonal drugs, fragments include degraded monoclonal antibodies and partially assembled heavy and light chains, such as LC, HC, HHL, HH, L, etc., while polymers include dimer, oligomer, or more complex polymers. Multimer may not only be an invalid component in the monoclonal antibody, but also one of the important reasons for the immunogenicity of the monoclonal antibody. Therefore, size heterogeneity is an indispensable test item in the optimization of the monoclonal antibody production process, production process control, and release analysis, and it is also one of the important indicators for the stability evaluation of the monoclonal antibody.
Purity determination is an important detection index for recombinant protein drugs, which directly reflects the level of antibody purification technology and product quality. There are two main problems in antibody purity determination. One is the efficient separation of antibody molecules from impurities. In practice, some impurities, such as peptide chain truncated or lengthened form, modified form, polymer, polymer, etc., may be difficult to separate because their properties are close to the main protein, so a suitable separation method must be selected. The second is the detection and quantification of major proteins and impurities. Due to the limitation of the sensitivity of various detectors, it is not easy to detect trace impurities introduced in some production purification processes and operating environments. Creative Proteomics professional analysts will use high-precision instruments and optimized technology to solve related problems for you.
To ensure the quality, safety and effectiveness of antibody drugs, Creative Proteomics has developed an antibody drug homogeneity analysis platform to speed up your project research. We are committed to becoming the most trusted biopharmaceutical partner, providing customers with high-quality, professional analysis services. Based on the platform approach required in the United States Pharmacopoeia and your specific requirements, we will customize your own analysis solution and deliver high quality analysis reports.
We Can Provide but Not Limited to:
- Antibody Purity Analysis
- Antibody Polymer Analysis
- Antibody Fragment Analysis
- Antibody Isoform Analysis
- Host Cell Proteins Analysis
- Host Cell Residual DNA analysis
Technology Platform of Antibody Homogeneity Analysis Service:
Creative Proteomics can combine a variety of technical methods to provide you with accurate antibody homogeneity analysis service.
1) Chromatography technology
- High performance liquid chromatography (HPLC)
- Size exclusion chromatography (SEC)
- Reversed-phase chromatography (RPC)
- Ion exchange chromatography (IEC)
- Hydrophilic interaction liquid chromatography (HILIC)
HPLC can effectively analyze the heterogeneity in antibody drugs and recombinant protein drugs. SEC takes advantage of the difference in molecular spatial structure and can effectively analyze samples such as antibody multimers, fragments, and PEGylated proteins. IEC, RPC, and NPC/HILIC provide high-resolution analysis of charged and structural isomers in antibodies, or impurities due to glycosylation, deamidation, and oxidation. SEC-HPLC method can determine the high molecular weight impurities (HMWS) and monomer content of monoclonal antibody drugs.
2) Capillary electrophoresis sodium dodecyl sulfate (CE-SDS)
Determination of low molecular weight impurities (LMWS).
Advantages of Antibody Homogeneity Analysis Service:
- Short time-consuming: The service adopts standardized analysis methods and high-efficiency data analysis software. At the same time, it adopts a fast and convenient sample processing procedure, which can greatly reduce the analysis time for antibody drug homogeneity.
- Professional platform: According to your purpose and budget, we suggest a suitable platform for you to conduct structural analysis.
- Rapid turnaround time: 5-7 days to provide complete analysis report.
Creative Proteomics' researchers can provide you with detailed experimental analysis programs, complete and comprehensive antibody homogeneity analysis reports and other bioinformatics analysis reports. We insist on focusing on customer needs and assist biopharmaceutical companies to better complete research projects in terms of technology and analytical solutions to accelerate the marketization of their products.
