Developability And Pre‑Formulation For A Faster Path To Approval

Dr. Andrea Hawe, Chief Scientific Officer

Early stages of drug development are critical, and delays or late‑stage failures often stem from issues that could have been identified much sooner. To avoid these setbacks, developers increasingly rely on two key tools: developability assessments and pre‑formulation screening. Developability assessments evaluate a molecule’s intrinsic properties—such as stability, manufacturability, and biophysical behavior—to determine whether it can realistically advance into large‑scale production and clinical testing. This process helps uncover potential problems early, before they become costly obstacles.

Pre‑formulation platforms complement this work by systematically screening excipients and conditions to define a formulation “corridor” that supports stability and performance. By gathering meaningful data early, teams can make informed decisions, reduce risk, and move more confidently into later development stages. Together, these streamlined platform approaches speed up development, improve predictability, and help drug candidates reach approval faster with fewer surprises.