Formulation, process, and analytical development for antibody - drug conjugates, or ADCs, is complex. While the development of 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 white paper provides an overview of:
ADC structure and function
The development process
Lyo cycle optimization