The Formulation Development Journey

By Katherine Bowers and Francisco Gonzalez

One of the most critical, yet often overlooked, aspects of a successful biological pharmaceutical is the formulation used to create a stable drug product for pre-clinical, clinical, and commercial applications. A molecule with great therapeutic potential is only as good as its shelf life and the amenability with the route of delivery.

Formulation development is a journey that FUJIFILM Diosynth Biotechnologies (FDB) travels with you, as a team partner, with the destination being a successful launch of your molecule into patient populations that are waiting for better treatments and cures for life-changing illnesses.

Successful formulation journeys start with a roadmap where scientific studies and decision points are used to create a route for understanding a molecule’s personality and its viability to help it along the way to the ultimate user – the patients. The roadmap is composed of molecular information that is collected using innovative, information-rich and scientifically-sound computational, biophysical and biochemical analysis.

In this article, review some of the critical statements and questions we ask to examine your molecule and understand its personality, including its strengths and liabilities.