Chemical Stability of Antibody Drug Conjugates

Chemical stability assessment is critical to ensure the efficacy and safety of antibody drug conjugates (ADCs) during drug development. Any factor contributing to the chemical instability of ADCs may affect the targeting ability of the drug and form toxic degradates, causing serious safety concerns. Therefore, more research is needed to adequately assess the chemical stability of ADCs in order to identify factors affecting the stability of ADCs at an early stage and to develop reliable manufacturing processes to consistently produce high-quality ADCs. Creative Proteomics offers comprehensive chemical stability studies of antibody drug conjugates. Our focus is centered on evaluating the chemical instability related to the conjugation process, antibody-drug ratio (ADR) and payload release kinetics. We thoroughly evaluate and monitor the chemical stability of coupled drugs throughout drug development and manufacturing to reduce heterogeneity and improve ADC stability.

Our Chemical Stability Analysis Services of Antibody Drug Conjugates

Chemical stability analysis services for ADCs involve a variety of analytical techniques and studies with a view to adequately assess the stability of these complex drug molecules from different aspects. Our focus in chemical stability analysis of ADCs is mainly centered on the following aspects:

Potential degradation studies of drug molecules

A variety of factors such as temperature, light, pH and oxidation can lead to the degradation of ADCs. Therefore, Creative Proteomics scientists evaluate the effect of ADCs on drug stability by subjecting samples of ADCs to different conditions and develop recommendations for proper storage and handling.

Chemical instability studies related to the conjugation process

The manufacture of ADCs requires a number of specific process steps to conjugate the drug moiety onto the antibody. This process can be chemically unstable, resulting in reduced efficacy or unwanted side effects. Creative Proteomics utilizes our advanced analytical technologies to comprehensively assess the impact of the manufacturing process on the stability of ADCs. By identifying and monitoring the chemical changes that occur within ADCs during the conjugation process, we can improve and optimize the manufacturing process in a timely manner to help our customers increase the stability of their drugs.

Linker stability analysis

Stability of the linker is critical to ensure the effectiveness of ADCs and to avoid off-target toxicity. Our expert team employs customized analytical strategies combined with our advanced platform technologies to assess the potential sensitivity of the linker to hydrolysis or cleavage. Evaluating the stability of linkers under different physiological pH, temperature, and enzymatic conditions helps clients gain a comprehensive understanding of the overall stability of ADCs.

Release kinetics studies of payloads

In the context of ADCs, studies of the degradation of the payload itself or its direct release upon coupling are important for the development and optimization of ADCs. Creative Proteomics accurately characterizes the release kinetics of ADCs by directly monitoring the release profile of the payload, providing insights into the stability and safety of ADCs.

Impurity or degradation product analysis studies

The formation of potential impurities or degradation products can affect the safety and efficacy of ADCs. Our advanced assays accurately detect and characterize impurities or degradation products that may be formed during the production, storage, and application of ADCs, helping our customers reduce potential safety and stability risks.

Our Analytical Techniques

Creative Proteomics has a wide range of powerful tools, techniques and methods for stability analysis of ADCs. Our team of experts has extensive expertise and experience in stability analysis and can provide customized analytical methods based on our clients' demands.

Techniques	Description
High-performance liquid chromatography (HPLC)	High performance liquid chromatography (HPLC) can be coupled with a variety of detectors, such as ultraviolet, fluorescence or mass spectrometry, for the effective detection and quantification of free connector drugs and other small molecule species.
Capillary electrophoresis (CE)	Separation and characterization of different antibody forms such as monomers, dimers and aggregates. Capillary electrophoresis can also be coupled with mass spectrometry to identify and quantify degradation products.
Mass spectrometry (MS)	MS can be used to identify and characterize degradation products, determine their molecular weights, and understand the degradation pathways.

Features of Our Chemical Stability Analysis Services

Customized stability testing solutions are developed with full consideration of the customer's product characteristics and development stage.
A multidimensional analytical strategy ensures a comprehensive assessment of the chemical stability of ADCs.
Our services cover a wide range of analytical techniques, including various spectroscopic methods, chromatographic techniques and mass spectrometry.

Creative Proteomics is dedicated to providing comprehensive, detailed analysis of the chemical stability of antibody drug conjugates to help provide valuable insights and benefits to our clients during the antibody drug development process. Contact us to learn more about our service and we will be happy to serve you.