In this Ardena Insight, we explore the critical role of solid-state screening in identifying stable polymorphs during drug substance (DS) development. Polymorphs, crystalline forms with the same chemical structure but different molecular arrangements—can dramatically impact solubility, dissolution, flow properties and overall processability.
Inadequate understanding of DS solid-state behavior can lead to unintended polymorphic conversions during processing or storage, affecting manufacturability, bioavailability and clinical outcomes. Switching between polymorphs during clinical development may also trigger the need for costly bridging studies to satisfy regulatory requirements.
At Ardena, we help you strike the right balance, providing expert guidance on when and how to invest in solid-state screening. Our tailored approach ensures that you mitigate risk without incurring unnecessary cost, aligning your development strategy with both scientific and regulatory expectations.
