ADC的制剂处方设计和优化

Formulation Design and Optimization of ADC

抗体偶联药物(antibody-drug conjugate,ADC)结合了单克隆抗体的靶向性和小分子物质的强大杀伤力,成为当前生物制药领域的研究焦点。虽然全球已有多种ADC上市,但在配方和稳定性方面仍存在挑战。该文从ADC的抗体、连接子和小分子物质选择的角度,概述了ADC配方开发和临床应用中的关键和难点,并提出了ADC使用期间的稳定性研究方案,旨在为未来ADC的开发提供参考。

Antibody-drug conjugates(ADC)combine the targeting ability of monoclonal antibodies and the potent cytotoxicity of small molecule substances,becoming a research focus in the current biopharmaceutical field.Although various ADCs have been marketed globally,challenges still exist in formulation and stability.This review outlines the key points and difficulties in ADC formulation development and clinical application from the perspectives of antibody,linker,and small molecule substance selection for ADC,and proposes a stability study plan during ADC use,aiming to provide references for the future ADC development.