Pharmaceutical Development For ADCs: Not As Simple As ABC

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