Impurity Analysis of Antibody Drug Conjugates

The complex structure of antibody drug conjugates (ADCs) results in complex impurity profiles that need to be evaluated by orthogonal combinatorial methods to accurately detect and limit ADCs product and process related impurities to acceptable standards. Creative Proteomics enables comprehensive detection and quantification of ADCs product and process-related impurities through accurate and reliable methods to ensure the safety and efficacy of ADCs. Our customized assay protocols and rapid turnaround times enable customers to make informed decisions about product quality quickly during the development of ADCs.

Contents of Our ADCs Impurity Analysis Services

• Purity and product-related impurities

Our team of experts determines the degree of aggregation and fragmentation in ADCs by measuring molecular size variants using precise and reliable methods. If possible, charge variants should also be determined using appropriate methods.

• Process-related impurities

Our ADCs characterization strategy also includes the analysis of process-related impurities. Using appropriate assays, our scientists can examine key impurities in the coupling process steps for the purpose of impurity control. These impurities typically include free small molecule drugs, coupling solvent residues, and more. Our assay results can help clients determine whether their ADCs development programs are compliant with the relevant regulatory limits.

Impurity Analysis Services of Antibody Drug Conjugates at Creative Proteomics

Creative Proteomics offers comprehensive, state-of-the-art solutions for impurity analysis of antibody drug conjugates. With our state-of-the-art technology platform and a team of highly skilled scientists, we are able to meet our customers' needs for impurity analysis of ADCs at any stage of development.

Details of the services we provide include, but are not limited to, the following:

• Method development and validation

Creative Proteomics develops robust and reliable impurity analysis methods for client-specific antibody drug conjugate products in accordance with relevant regulatory guidelines. The developed methods are fully validated by our experienced scientists to help our clients address all the challenges of impurity analysis of ADCs to support successful product registration.

• Identification and characterization of impurities

To characterize and build impurity profiles, we use a range of advanced analytical techniques such as Liquid Chromatography-Mass Spectrometry (LC-MS) and Capillary Electrophoresis (CE) and provide expert data interpretation.

• Quantification of impurities

In the lab at Creative Proteomics, we have developed a range of proven methods to accurately quantify impurities in antibody drug conjugates. Our highly sensitive and accurate detection techniques can accurately quantify any potential impurity contamination in ADCs products and processes, even at trace levels.

• Degradation studies

We evaluate the stability and potential degradation pathways of ADCs by subjecting samples of ADCs to different stress conditions. This process helps to identify impurities generated during storage of ADCs products and provides insights for ADCs development.

Our Impurity Characterization Method for ADCs

Creative Proteomics' team of experts has extensive knowledge and expertise in antibody-coupled drug impurity analysis. We stay abreast of the latest technology and industry advances and apply them to your ADCs impurity characterization. Contact us to learn more about our service and we will be happy to serve you.