Assessing Developability And Designing Advanceable Formulations From The Start

By Nazar Elkarim, Ph.D., Vice President, Product Development Services, Mikart

Early-stage developability assessments are essential for evaluating both therapeutic potential and manufacturability, enabling pharmaceutical teams to identify the most viable drug candidates early while efficiently eliminating those with limited promise. When paired with a quality-by-design (QbD) framework, these assessments lay the foundation for robust, efficient manufacturing processes and flexible formulations that can adapt as development requirements evolve.

In our latest article, we examine how early developability strategies reduce risk, shorten timelines, and improve decision-making by aligning scientific innovation with practical execution. We also explore how applying QbD principles enhances long-term efficiency, supports regulatory readiness, and minimizes costly late-stage changes. Finally, the article highlights the importance of designing advanceable formulations with bioavailability, scalability, stability, manufacturability, and compliance in mind — key factors that collectively accelerate development timelines and drive greater cost-effectiveness from discovery through commercialization.