Understanding the importance of crystallization processes to avoid unnecessary cost, risk and development delays
Crystallization is often the ultimate step of a drug substance manufacturing process prior to isolation and drying. A robust crystallization process can allow many benefits, such as isolation of a desired polymorphic form, optimization of purity through exclusion of impurities, and enhanced yield. Additionally, a crystallization process can allow physical properties of a batch of particles to be optimized. An API’s particle size distribution, particle morphology and flow properties can also have a significant impact on the downstream processing that it will have to endure en-route to a formulated drug product. Filtration, washing, drying and formulation can all be enhanced, and product consistency improved, by adopting a suitable, well developed crystallization process that targets suitable particles by design.
This webinar will:
- Provide an introduction and overview of the importance of crystallization in the pharmaceutical industry
- Discuss the workflow of a crystallization process development program at Cambrex Edinburgh
- Consider examples of typical issues faced during the crystallization process development of an API
- Discuss case studies where careful control of the crystallization has allowed processing problems to be overcome
Cambrex’s Edinburgh site is a world-leader in providing solid form development services for drug substance and drug product.
Dr Craig Callahan, Project Scientist, Cambrex Edinburgh