Small Molecule Antibody Drug

Small molecule antibody drugs, i.e. antibody fragments, are part of full-length antibodies. These fragments have attracted considerable attention in the therapeutic field due to their unique properties and potentially favorable efficacy. Creative Proteomics provides comprehensive characterization services for potential small molecule antibody drugs, including fragment antigen binding (Fab), single-chain fragment variable (scFv), single-domain antibody (sdAb) and other different types of antibody therapeutic molecules. Our experienced experts can provide customized characterization services and the best analytical techniques to support their drug development efforts according to their demands.

Introduction of Small Molecule Antibody Drugs

Small molecule antibody drugs are smaller in molecular size compared to full-length antibodies, retain the specificity of intact monoclonal antibodies and have better pharmacokinetic properties in terms of tissue or tumor penetration. Antibody fragments have demonstrated therapeutic potential in a variety of applications, including cancer therapy, immune disorders, infectious diseases and diagnostics. Like any other therapeutic molecule, the successful development of small molecule antibody drugs requires thorough, careful characterization based on the nature of the antibody fragment, its intended use, and regulatory requirements to ensure its quality, safety, and efficacy.

Fig. 1 The schematic representation of an antibody and its derivatives. (Muñoz-López, P. et al., 2022)

Our Characterization Scope

Creative Proteomics has extensive experience in the characterization of the following small molecule antibody drugs:

Fragment antigen binding (Fab)

Fab fragments consist of variable structural domains of the heavy and light chains of an antibody and are prone to aggregation and instability due to the lack of an Fc region. Creative Proteomics provides comprehensive characterization services for Fab fragment-based antibody drugs and focuses on stability-related issues due to their structural properties in order to optimize the production, storage, and administration of such antibody drugs.

Single-chain fragment variable (scFv)

scFv-based fragments have been used to target antigens associated with human diseases and therefore have been designed in larger, multivalent, bispecific and coupled forms for clinical applications. At Creative Proteomics, we provide detailed characterization services of scFv-based antibody drug molecules based on their unique structures and properties to ensure their efficacy and safety as therapeutic agents.

Single-domain antibody (sdAb)

Single-domain antibodies, also known as nanobodies, are antibody fragments derived from the variable regions of heavy-chain-only antibodies found in camelids and sharks. Our comprehensive characterization services enable effective evaluation of this promising therapy. By providing information on the physicochemical properties, activity and stability of sdAb antibody drugs, we help our customers optimize their development and accelerate the discovery of more effective antibody therapies.

Small Molecule Antibody Drug Characterization Services Provided by Creative Proteomics

The development and optimization of antibody fragment drugs requires careful consideration of structure, efficacy, stability, pharmacokinetics and immunogenicity, etc. Creative Proteomics can provide customized solutions to fully characterize the key quality attributes of these antibody therapeutics based on the customer's stage of development and demands.

• Structural characterization: comprehensive characterization of molecular weight, primary structure and advanced structure of small molecule antibody drugs using advanced mass spectrometry, chromatography and other techniques.
• Post-translational modification characterization: identify and quantify post-translational modifications such as glycosylation, oxidation and other post-translational modifications using mass spectrometry, peptide mapping or glycan analysis techniques to ensure product consistency and stability.
• Functional characterization: the binding activity, specificity and function of antibody therapeutic fragments are comprehensively analyzed and evaluated by a multi-technology combination of surface plasmon resonance (SPR), cell-based assays and in vivo modeling.
• Purity and impurity characterization: We use analytical techniques such as size exclusion chromatography (SEC), capillary electrophoresis (CE), or mass spectrometry (MS) to accurately identify any potential impurities and contaminants, such as aggregates, to ensure the purity and safety of your drug.
• Stability assessment: We analyzed the stability of these antibody fragments by evaluating the effects of various stress conditions on their integrity, aggregation propensity and degradation.

Why Choose Us?

• Comprehensive characterization services ranging from structural analysis and binding kinetics to stability assessment and immunogenicity analysis.
• Tailor-made characterization strategies based on the characteristics of different small molecule antibody drug structures and activities.
• Efficient project management and effective communication ensure timely delivery of analysis results and provide expert data interpretation.

Characterization Service Process

At Creative Proteomics, you can get comprehensive small molecule antibody drug characterization services by following these simple steps.

Creative Proteomics is committed to providing comprehensive, detailed small molecule antibody drug characterization services to support your drug development efforts and help you achieve your goals. Contact us for more information and we will be happy to assist you.

Reference

1. Muñoz-López, P.; et al. Single-chain fragment variable: recent Progress in cancer diagnosis and therapy. Cancers. 2022, 14(17): 4206.