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