Efficacy and Safety - Guidelines for Clinical In-use Stability Studies of ADCs Download

Antibody-drug conjugates (ADCs) consist of three parts: antibody, linker, and payload. This special combination enables ADCs to selectively target tumor cells and release cytotoxic drugs, but they face many stability challenges during manufacture, storage, and clinical use. In this paper, the drug product development team at Porton (hereinafter referred to as "we") discusses the necessary clinical in-use stability studies for ADCs. At present, the 16 ADCs currently on the market employ intr