Solid State Chemistry is the study of structural and physical properties such as solubility and powder flow and is closely tied to technical crystallization, which designs the processes that ensure that your solid phase materials have the required properties for further development. Polymorph and salt screens, crystallization process development and solid state analysis go hand-in-hand to identify and generate solid phases of a given material and characterize their microscopic features and macroscopic properties.
API with poorly understood physical properties and/or a poor crystallization process can have significant impact upon downstream process development, drug product formulation and product performance which can lead to delays in achieving development milestones or even lead to product failure.
Changes to drug substance can occur in early and late stage lab development or manufacturing prior to process validation, driven by process/scale changes and even clinical requirements. Unless each batch is characterized, undetected solid form inconsistencies can cause significant delays to clinical development.
By selecting the optimal solid form early, this will ensure you have the pathway you need for successful product development and scale up. Our solid state capabilities include:
Across a global network, Thermo Fisher Scientific integrates Small Molecule API, Solid State Chemistry and drug product development to produce formulation enabling API to speed your product development to the next milestone. Contact us to discuss our API development services.
Download this factsheet for an overview of Solid State Chemistry for product development.