Don't Let Formulation Failures Derail Drug Development

By Nazar Elkarim, Ph.D. — MIKART

Modern pharmaceutical pipelines increasingly feature structurally complex molecules — including HPAPIs, orally delivered peptides, and GLP-1 therapeutics — that introduce formulation and manufacturing challenges well beyond those of conventional small molecules. Roughly 40 percent of new chemical entities face developability hurdles, yet many organizations continue to defer assessment in pursuit of speed to market, creating compounding technical and financial risks downstream.

Early engagement with a technically sophisticated CDMO offers a more sustainable path. By evaluating drug substance and drug product attributes from the outset, sponsors can proactively identify solubility, permeability, polymorphic, and containment liabilities before they escalate into costly late-stage problems. Structured Quality-by-Design frameworks and risk-based control strategies developed early preserve both clinical viability and commercial feasibility.

The financial case is equally compelling. Programs that skip early developability assessment frequently face reformulation cycles, bridging studies, regulatory remediation, and clinical delays, all of which inflate total development cost and erode competitive positioning. Conversely, early CDMO integration streamlines formulation selection, strengthens supply chain resilience, and shortens the timeline to first-in-human studies.