Physical Stability of Antibody Drug Conjugates
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Evaluating the physical stability of antibody drug conjugates (ADCs) is particularly important in the development, production and formulation of antibody drugs. The stability of antibody drug conjugates is affected by a variety of factors such as storage temperature, oxidation, light, ionic strength and shear stress. These factors affect various physical properties of ADCs such as solubility, aggregation, viscosity and appearance. In addition, coupling of small molecule drugs to the parent molecule alters the physicochemical properties of the antibody coupled drug and also affects its degradation profile. Therefore, the use of appropriate analytical tools to monitor physical stability changes is necessary to identify critical product quality attributes such as aggregation. Creative Proteomics has established a comprehensive ADCs stability analysis platform. Our team of experts conducts comprehensive analyses of the physical stability of ADCs to ensure the quality, safety and efficacy of antibody drug conjugates by employing appropriate stress conditions and using stability-indicating analytical methods to detect degradation products.
Overview of Physical Stability Analysis Services of ADCs
Physical stability analysis of ADCs can provide information about the integrity and effectiveness of a drug. By performing stability analysis, potential problems with the drug can be identified and resolved at an early stage, so that the stability of the drug can be improved by optimizing the development process, modifying formulation parameters, and other measures. In addition, stability analysis can help determine optimal storage conditions and packaging materials to extend the shelf life of antibody drug conjugates. The ADC physical stability analysis service provided by Creative Proteomics focuses primarily on evaluating physical stability of antibody drug conjugates as well as temperature-induced or photo-induced instability.
- Physical stability of antibody drug conjugates
Study of the physical stability and degradation of ADCs primarily addresses mAb aggregation, and the increased propensity for aggregation brought about by processing steps or the physical impacts of the linker and drug modifications.
- Temperature-induced or photo-induced instability
Antibody drug conjugates are analyzed for short- and long-term stability by exposing them to stressful conditions such as heat and light to accelerate the emergence of potential instability problems, ensuring a comprehensive understanding of the product's stability under various conditions.
Our Analytical Techniques
We offer a variety of advanced techniques for physical stability analysis of ADCs, including but not limited to:
| Techniques |
Description |
| Size exclusion chromatography (SEC) |
Detecting the presence of aggregates in ADCs and measuring their content. |
| Dynamic light scattering (DLS) |
Measurement of the particle size distribution of antibody drug conjugates, thus helping to detect changes in drug aggregation over time. |
| Differential scanning calorimetry (DSC) |
DSC recognizes conformational changes with the ability to assess the stability and denaturation temperature of antibody drug conjugates. |
| Mass spectrometry (MS) |
Mass spectrometry techniques provide insight into the higher order structures and conformational changes of drugs. |
| Viscosity measurements |
The integrity of the antibody drug conjugates is determined by assessing any changes in the viscosity of the solution that may indicate particle formation or aggregation. |
Features of Our Physical Stability Analysis Services
- Customized stability testing solutions are developed with full consideration of the customer's product characteristics and development stage.
- Comprehensive stability studies, including accelerated degradation studies, forced degradation studies, long term stability studies, freeze-thaw studies, and light stability testing.
- A variety of advanced analytical techniques ensure that customers are provided with the appropriate analytical tools to monitor physical stability changes.
Creative Proteomics' experts provide comprehensive physical stability analysis services for ADCs to clients worldwide, ensuring that their products remain stable, safe and effective throughout the entire process from development to commercialization. Contact us to learn more about our service and we will be happy to serve you.
