Right From The Start: Smarter Developability For Stronger Formulations

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

In today’s fast‑moving pharmaceutical landscape, early developability assessment has become essential for reducing risk and accelerating the path from concept to clinic. This article explores how incorporating manufacturability, scalability, and formulation flexibility from the very beginning can prevent costly late‑stage setbacks and improve a molecule’s chances of commercial success. By treating developability as a strategic filter, teams can generate meaningful data that evaluates not only safety and efficacy, but also a compound’s ability to be formulated, scaled, and produced reliably.

See how a Quality‑by‑Design (QbD) framework strengthens formulation development through structured experimentation and robust design spaces. It also explains why simple, advanceable formulations are ideal in early stages, enabling rapid iteration as clinical or regulatory needs evolve. Underutilized dosage forms like sachets are presented as versatile tools that support precise dosing and enhanced stability.

Finally, the article underscores the value of integrated CDMO capabilities that seamlessly bridge early formulation work with GMP‑ready manufacturing.