Investing in solid state characterization and crystallization development early in the drug development journey can help accelerate speed to market and avoid costly mistakes down the road. By fully understanding the solid form landscape upfront, biopharma companies can develop a scalable crystallization process that achieves the desired purity.
Another important consideration is identifying and choosing a suitable form to take into formulation —one that has good bioavailability and can be readily processed in drug product manufacturing. Defining solid state parameters early on, when flexibility is greatest, helps to ensure better control over the end-to-end drug substance and drug product process.
By partnering with a CDMO like Thermo Fisher Scientific, biopharma companies can better understand the properties of their APIs and support the development of a scalable crystallization and formulation process.
Watch our on-demand webinar to learn about the benefits of early solid state and crystallization development and explore case study examples.