Opening the Black Box | Understanding Solid Form and Crystallisation

Choosing the ideal solid form is a crucial point in the life cycle of a molecule. Therefore, it is always best to conduct a thorough search to identify as many forms (polymorphs, salts and cocrystals) as possible to allow you to select the one with the preferred physical/chemical properties and for IP. However, limited material can make this challenging. A well-designed screen, including multiple crystallisation techniques with a diverse set of solvents, can be carried out with little material prioritising analytical techniques to identify solid forms of interest. Furthermore, as a solid form progresses through development, unexpected issues can arise. New forms, oiling out, change in impurity profiles caused by changes in scale, can result in the scrapping of batches, extra production steps or the reset of a molecule potentially costing millions. To minimise risk, crystallisation development driven by Quality by Design (QBD) should be undertaken as soon as possible. Using PAT tools, modelling, design of experiment studies coupled with expert understanding of the solid form and solubility landscape, a scalable, robust process that will give the desired outcome can be built and developed at an early stage of development.

This webinar was presented by Dr Thomas Kendall from Johnson Matthey, who kindly sponsored the session.

You can view the Q&A using this LINK