ADC Product Characterization

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Antibody-drug conjugates (ADCs) are a type of targeted cancer therapy that combines the targeting ability of an antibody with the cytotoxic effects of a chemotherapeutic drug. The antibody is used to specifically target cancer cells while the drug is used to kill the cancer cells. ADCs can be used to treat a variety of different types of cancer, including hematological malignancies and solid tumors. It is important to characterize Antibody-drug Conjugates in order to understand the pharmacokinetics of the drug, the stability of the conjugate, and the effectiveness of the drug in targeting the desired cells. It is the process of testing and evaluating the performance and accuracy of ADCs. Characterization also helps to determine the optimum drug-to-antibody ratio for the desired effect, and to understand any potential toxicities that may occur. Antibody-drug conjugates (ADCs) characterization typically involves a range of tests and measurements to assess the potency, purity, and stability of the drug. These tests typically include high-performance liquid chromatography (HPLC) to measure potency and purity, as well as stability studies to assess the drug's stability over time. Additionally, ADCs should be tested for immunotoxicity to ensure they are safe and effective for use in patients. And it is important to test the ADCs for linearity of output and noise immunity. This is a critical step in the design process of any application involving an ADC, and should be completed prior to deployment.

Although the characterization of ADCs and determination of DAR values seem straightforward and analytically feasible, ADCs are substantially more complex than either "unconjugated" mAbs or small drug molecules. This complexity is due to their combined chemical linker and the heterogeneous distribution of conjugation sites. Therefore, ADC characterization and stability (or DAR value) monitoring can be challenging. ALL Chemistry Inc.’s experts have considerable knowledge of the scientific background to this product class, which experienced in large molecule bioanalysis and characterisation. ALL Chemistry Inc. can provide various analytical techniques, such as UV-Vis, fluorescence, DSC, HIC, 2D-LC/MS, and SEC followed by MALS detection to analysis ADCs chemical stability issues and determine DAR values. For more information, please contact us. Our customer service representatives are available 24 hours a day, Monday through Friday, to assist you.

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