Analysis and characterization of Antibody-Drug Conjugates (ADC)
Do you need analysis and characterization of your antibody-drug conjugates (ADC)?
Analysis and characterization of antibody-drug conjugates (ADC) is a important step to ensure their safety, efficacy, and quality before clinical use.
Given the complexity of these molecules, which combine a monoclonal antibody (mAb), a cytotoxic agent, and a chemical linker between the two, the analysis must be thorough and multidimensional.
This laboratory analysis includes the evaluation of the antibody’s structure, characterization of the chemical linker (conjugation), and the distribution of the cytotoxic load on the antibodies.
Advanced techniques such as mass spectrometry, liquid chromatography, and biological assays are used to verify the conjugate’s purity, stability, and efficacy.
Additionally, it is essential to detect and quantify impurities and degradation products, as well as to assess the product’s stability under various storage conditions.
This rigorous analytical approach ensures that ADCs meet guideline (ICH Q6B) and are safe and effective for patient treatment.
Our solutions for your ADC analysis and characterization needs
FILAB, an analytical expertise laboratory, has strong expertise in the analysis and characterization of antibody-drug conjugates (ADCs) in accordance with current guidelines, including ICH Q6B.
With this expertise, we design custom analyses to meet your specific needs at different stages of development, from preclinical characterization studies to research and development.
Our analytical services are customizable throughout the development and production lifecycle, with a particular focus on critical quality attributes (CQAs) and drug-to-antibody ratio (DAR) identification of your ADCs.
The FILAB laboratory offers a full range of analytical services for the characterization and analysis of antibody-drug conjugates, including the evaluation of DAR.
FILAB offers a comprehensive range of services for the characterization and analysis of antibody-drug conjugates (ADC), including DAR evaluation
Structural analysis and characterization of ADCs
Determination of the average DAR
Reduced forms (HC, LC, Fab, FC)
Physicochemical property analysis and characterization
Our laboratory provides accurate data regarding the size, mass and physicochemical properties of ADCs. This information is essential for the development, validation and quality control of these antibody-drug conjugates (ADC).
Impurity identification in biopharmaceutical products
Other impurities (compliance with ICH Q3D, E&L, etc.)
For process-related impurities, our laboratory performs specific tests, including the quantification of elemental impurities in accordance with USP 233 and ICH Q3D standards.
We also perform extractables and leachables (E&L) analyses.
In addition, we analyze cell culture media (amino acids, vitamins, saccharides) to ensure the quality of bioproduction processes.
