Case Study
Pharmaceutical Development for ADCs
Formulation, process, and analytical development for ADCs is complex. While an aqueous solution formulation may be preferred over a lyophilized product, it is useful to initially pursue a dual path and develop drug product formulations for both a sterile solution and a freeze-dried solid presentation, ultimately choosing the most successful candidate for final development.
This presentation provides an overview of ADC structure/ function, the development process and a case study demonstrating importance of determining the optimal residual water content of the freeze-dried solid.
