Structural & Physicochemical Analysis
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Antibody drugs have very high requirements for quality characterization due to their large molecular weight and the ease of introducing post-translational protein modification changes, size variants, charge variants, and even aggregation to form particles due to the expression system and process. Creative Proteomics offers a comprehensive portfolio of services and technologies for the structural and physicochemical characterization of antibody drugs. This service can provide valuable insights into the manufacturing process, stability and efficacy of antibody drugs, enabling manufacturers to optimize their processes and improve the performance of their drugs in clinical trials and in the marketplace.
Purpose of Structural and Physicochemical Characterization of Antibody Drugs
Structural and physicochemical characterization of antibody drugs is essential to understand their performance, efficacy and safety. In addition to comprehensively characterizing the quality of antibody drugs, another core objective of the assay is to find key amino acid residues and post-translational modifications of key amino acids that may affect the efficacy of antibody drugs, and to perform relevant process modification and confirmation to avoid adverse effects in the late stage of process development as well as in the clinical stage.
Antibody Drugs Structural and Physicochemical Characterization Services at Creative Proteomics
The process of antibody drug development, filing and manufacturing is accompanied by the study and control of product quality. Antibody drug quality analysis involves several aspects. Among them, the confirmation of structural and physicochemical properties is a necessary element for the registration and filing of antibody drugs and requires a comprehensive testing portfolio, which usually includes the following aspects:
We perform a comprehensive characterization of the molecular weight of antibody drugs from four aspects. Rapid and accurate molecular weight quantification can be achieved by using LC/MS-based methods.
Primary structure characterization is fundamental to ensuring the quality, safety and efficacy of antibody drugs and involves the use of a variety of analytical techniques to determine and characterize the molecular weight, amino acid sequence coverage and N/C-terminal sequence of antibodies. comprehensive characterization of the primary structure of antibody drugs.
The folding of the antibody backbone and the disulfide bond linkages between the different chains allow the spatial structure and activity of the antibody to be maintained. Creative Proteomics has established well-established analytical techniques and methods for the characterization of advanced structures of antibody drugs. These techniques allow for the accurate identification and quantification of various structural features, conformational stability and binding affinity of antibodies. The results of their characterization are critical to understanding the mechanism of action of antibody drugs, predicting pharmacokinetics and pharmacodynamics, and ensuring quality and safety.
The post-translational modification status of proteins affects the stability, efficacy, pharmacokinetics and drug safety of antibody drugs. Our experienced project team is able to accurately and reliably characterize a wide range of modifications using advanced mass spectrometry techniques.
Aggregate analysis is a key part of antibody drug development, used to ensure product quality, safety and efficacy. Creative Proteomics performs aggregation analysis of antibody drugs using techniques such as size-exclusion chromatography (SEC), analytical ultracentrifugation (AUC), and dynamic light scattering (DLS), with the goal of identifying and quantifying any aggregated species present, determining their size, shape, and composition, and assessing their impact on the quality and efficacy of the product.
Thermal stability is the ability of a protein to maintain its structural and functional integrity under different temperature environments and is an inherent property of monoclonal antibodies that can affect product stability during manufacturing and storage. In Creative Proteomics’ lab, we help our clients obtain thermodynamic parameters of antibody drugs by performing high-throughput thermal stability screening of samples using various advanced techniques such as differential scanning calorimetry (DSC), isothermal scanning calorimetry (ITC), and dynamic thermodynamic analysis (DTMA).
The degree of antibody heterogeneity not only reflects the consistency of the antibody production process, but also affects the stability, pharmacokinetics and immunogenicity of the antibody drug. Therefore, characterization and quality control of charge heterogeneity is crucial. We perform a comprehensive analysis of the charge heterogeneity profile of antibody drugs using state-of-the-art analytical techniques, including ion exchange chromatography (IEX) and capillary isoelectric focusing electrophoresis (cIEF).
Why Choose Creative Proteomics?
Characterization of your potential targets is very important when selecting quality antibody drug candidates. A complete structural and physicochemical characterization will maximize the chance of ensuring a smooth project. Creative Proteomics has the following advantages in antibody drug characterization:
The technical team has extensive project experience in biopharmaceutical characterization and analysis
Comprehensive stratified characterization methods covering physicochemical properties, biological activity, immunological properties, pharmacokinetics, purity, impurities, stability and safety studies.
- Precision instrumentation
We have a variety of advanced equipment such as mass spectrometry, liquid phase, and peptide fingerprinting analysis.
Short project turnaround time for accurate results delivery in a short period of time.
Let us be your partner in antibody drug discovery with Creative Proteomics' comprehensive antibody drug characterization services platform. Our experience in characterizing different types of antibody drugs maximizes your project's success. Contact us today to learn more about the structural and physicochemical characterization of antibody drugs.
