By Dr. Rajni Miglani Bhardwaj, Ph.D.
Associate Research Fellow, Pfizer

Commercial solid form selection is one of the key milestones during drug product development. It is also critical as product recall due to solid state form change compromises patient safety, damages company’s reputation and puts economic burden on company in redeveloping the drug product. Experimental screening is typically utilized to explore the solid form landscape of given molecules and select the solid form with optimum properties. Over the past decade, with the advancement of computational tools i.e., (crystal structure prediction, solid form informatics etc.), pharmaceutical industry has witnessed an ever-increasing utilization of these tools to complement experimental solid form screening and derisk solid form selection. In this presentation, we will be discussing how experimental and computational approaches are used in conjunction for solid form design and selection process. Case studies will be presented where combined application of experimental and computational approaches were used in conjunction to underpin the link between the structural features and derived properties and to highlight how computational tools provide an opportunity to gain fundamental understanding at molecular and crystal structure level which can help with assessing risks and developing mitigation strategies around solid form development.