Formulation Development Strategies for Monoclonal and Bispecific Antibodies

3/16/2021 11:35 - 12:10

Last couple of decades have witnessed significant growth of biopharmaceuticals; they are now playing pivotal role in the management of several diseases. Currently, they constitute around 30% of all the novel drugs approved each year; majority of biopharmaceuticals are proteins and monoclonal antibodies. Formulation development is an integral part of product development and is often used as a differentiating attribute. Multiple drug product presentations are employed during clinical development and commercial launch. Strategy of their development and timing of their launch are critical and defines product development efficiency. Increased importance of bispecifics/trispecifics have further made the formulation and drug product development   very important from strategic point of view.

Sachin Dubey, Senior Associate Director, Drug product and Analytical Development, Ichnos Sciences SA