Antibody-Drug-Conjugates (ADC) have emerged as an efficient technology to deliver cytotoxic drugs into cancerogenic cells. The mechanism is based on an antigen-mediated uptake of a cytotoxic drug conjugated antigen via clathrin-mediated endocytosis and release of the drug after lysosomal cleavage to its intracellular target.
With 14 ADCs currently approved worldwide, ADCs have proven their therapeutic value in increasing efficacy and reducing toxicity especially in oncology. Recent research however has shown that the cytotoxic drug mechanisms, drug-antibody ratio, antibody penetration and processing, resistance and off-target drug effects of ADCs can be further enhanced.
This continues to drive high investments into ADC research and development increasing the demand for external partnerships and expert support.
Translating the drug design concept of an ADC into a final product remains a major challenge. The cytotoxic small molecule drug can covalently bind to the monoclonal antibody at multiple sites during the synthesis leading to a heterogeneous mixture of unfavorable ADC products. In order to move into the preclinical and early clinical phase the exposure-response relationship for efficacy and safety must be established. For IND/IMPD filing, a bioanalytical strategy tailored to each of the ADC components is required by the regulatory authorities.
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