Clinical efficacy of ADCs is determined by fine-tuning combination of tumor antigen, targeting antibody, cytotoxic payload and conjugation strategy. ADC binds to tumor target cell surface antigens triggering a specific receptor mediated internalization. The internalized ADCs are decomposed to release cytotoxic payloads inside the tumor cell.
AMSbiopharma provides a particular key characterization analysis for ADCs such as: Drug antibody ratio (DAR) and Drug conjugation size.
Moreover, as stated in the ICH guideline Q6B, AMSbiopharma provides a comprehensive catalog of services required for the characterization of a biopharmaceutical.