Development and validation of an antibody-drug conjugate bioassay

Antibody-drug conjugates (ADCs) are a class of drugs used in the treatment of different cancers.

Unlike chemotherapy, ADCs are designed to only target and kill tumour cells. Structurally, ADCs are complex molecules composed of an antibody linked to a cytotoxic compound through the use of a linker. ADCs therefore combine the targeting capacity of monoclonal antibodies and the capacity to destroy cancer cells of cytotoxic agents.

In this context, Quality Assistance has developed a cytotoxicity assay using trastuzumab emtansine (T-DM1). T-DM1 is an ADC that combines the humanised trastuzumab antibody (anti-HER-2) and the potent anti-microtubule agent DM1 (derivative of maytansine) using a highly stable linker. This ADC is used as treatment for patients diagnosed with a HER-2 positive breast cancer. This study demonstrates the successful development and validation of this method.