Formulation Development for an Antibody Drug Conjugate (ADC)

Seminar given by Gregory A Sacha, Ph.D.
Senior Research Scientist
BioPharma Solutions
Baxter Healthcare Corporation
Bloomington, IN

Abstract: Antibody drug conjugates (ADCs) are a type of therapeutic biologic composed of a monoclonal antibody attached to a linker system that allows the antibody to carry individual molecules of chemotherapeutic compounds. ADCs are specific to antigens expressed by certain cancer cells and this allows that antibody to attach to the cancer cell and deposit the chemotherapeutic molecules.  This greatly reduces the amount of chemotherapeutic agent needed to treat the cancer and avoids attacking non-cancerous cells.  Most ADCs are lyophilized to improve stability and extend the shelf-life of the formulation. This presentation examines formulation development for a specific ADC and compares data used to evaluate the formulation.