Formulation: The Key To Long‑Term Success

By Michaela Breitsamer, Dr. rer. nat., Group Leader Formulation

A robust formulation is fundamental to long‑term drug development success, ensuring that biologic therapies remain stable, safe, and effective throughout their full lifecycle. This article emphasizes that robust formulations are built through a strategic, science‑driven approach that unifies deep molecular understanding, early predictive modeling, platform‑based assessments, and process‑informed development practices. With biologics typically requiring 24–36 months of refrigerated shelf life, achieving robustness is essential for maintaining critical quality attributes (CQAs) over time.

Because formulation performance is intertwined with manufacturing behavior, the article stresses the importance of approaching robustness as a long‑term, phase‑appropriate strategy rather than a late‑stage correction. A successful path begins with a strong understanding of the molecule, its clinical use, target product profile (QTPP), and required CQAs. These early insights shape a design space that guides stability, scalability, and future commercial feasibility.