Higher Order Structure Analysis
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Higher order structural characterization services allow for a comprehensive analysis of the higher order structure of antibody drugs, aiming to determine the secondary, tertiary and quaternary structure of the antibody drugs, as well as any modifications or variations present. Creative Proteomics' team of experts can provide accurate, comprehensive analysis, drawing on many years of experience in this field. Our expertise allows us to help our clients reveal the complex higher order structure (HOS) of antibody drugs to ensure their safety, efficacy and pharmacological properties.
Why Higher Order Structure Analysis of Antibody Drugs?
Maintaining the correct higher-order structure is essential to ensure the functionality, stability, and interaction with target molecules of an antibody drug. Higher-order structure is an important element of the CQA examination of an antibody drug's critical quality attributes, and can provide valuable information about an antibody drug's conformational stability, aggregation propensity, and immunogenicity. This data can help clients make informed decisions during the drug development process, which is critical to ensuring regulatory compliance and improving the quality and performance of antibody therapeutics.
Higher Order Structure Analysis Services at Creative Proteomics
Higher order structure (HOS) of biotherapeutics including its secondary, tertiary and quaternary structure is giving each biologic a spatial shape and impacts its function. Higher order structure analysis is used to study antibody-antigen interactions and to probe changes in the three-dimensional structure of antibody-based therapeutics that result from formulation in different buffers, degradation processes, post-translational modifications or drug conjugation.
The advantage of our higher order structure analysis service is the ability to detect antibodies at high resolution, providing different levels of structural information as follows:
- Secondary order structure: Secondary structures reflect the localized folding pattern of the antibody protein chain, most commonly the α-helix and β-sheet. The secondary structure of an antibody drug is essential for stabilizing the overall three-dimensional structure of the protein.
- Tertiary order structure: The tertiary structure is the overall three-dimensional (3D) shape of the protein. This shape is affected by interactions between different regions of the protein, including hydrophobic, electrostatic and hydrogen bonding interactions. Incorrect shape can directly affect the efficacy of a drug.
- Quaternary order structures: Quaternary structure is when multiple antibody molecules are arranged to form a larger protein complex. Some antibody drugs, such as IgG antibodies, have a quaternary structure in which two identical heavy chains and two identical light chains come together to form a Y-shaped structure.
Techniques for Higher Order Structural Characterization
Our scientists are well aware that comprehensive structural characterization of antibody drugs cannot be achieved by a single method, as none of the existing methods alone can provide sufficient information about the primary and higher-order structures of biosimilar drug candidates and their microvariants.
Creative Proteomics offers a wide range of advanced biophysical techniques, including:
We can choose the best analytical technique according to customer needs to fully characterize the higher order structure and stability of proteins and help customers gain insight into the molecular characteristics of antibody drugs. Avoid quality and safety issues caused by incorrect higher-order structure.
Creative Proteomics, as a specialized service provider in this field, our analytical team is also experienced in responding to industry and regulatory requirements to help clients obtain accurate and reliable analytical data in a time- and cost-effective manner. Contact us to learn more about our advanced higher order structure analysis services. We will be happy to assist you.
