How the "magic bullet" technology flow helps optimize the ADC drug conjugation process

Since ADC is composed of three parts: antibody, cytotoxic drug and linker, the complexity of this structure determines that the preparation process of ADC drug will be more complex
than that of monoclonal antibody and other drugs.
In the preparation process of ADC drugs, it is necessary to comprehensively consider a variety of factors, such as antibodies, linkers, conjugation methods, and the selection of cytotoxic drugs, as well as the drug-antibody ratio, drug load distribution, free drug clearance, etc
.
These factors are intertwined, and problems in any one link may prevent ADC drugs from achieving good results
.
Therefore, overly complex preparation processes are one of
the challenges in ADC drug development.

One of the most important quality attributes of ADCs is the average number of conjugate drugs (DAR) , as this determines the "payload" that can be delivered to the tumor, which can directly affect safety and efficacy
.
Therefore, building an ADC with stable and uniform DAR values is the focus
of process optimization in the ADC coupling step.
In the early coupling optimization process, the DAR value may be affected by factors such as temperature, pH, stirring speed, antibody concentration, dosing amount and dosing rate, which is often challenged
in the process of traditional equipment optimization.