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 Craig.Callahan@cambrex.com
Dr Callahan joined Cambrex following the acquisition of Solid Form Solutions, part of Avista Pharma Solutions, in January 2019. Dr Callahan’s role at Cambrex’s Edinburgh facility is to develop crystallization processes for client APIs with a view to obtaining robust and reliable isolation of particles with consistent physical properties. Prior to joining Cambrex, Dr Callahan achieved a PhD from the Chemical Engineering department of Heriot-Watt University, Edinburgh, where his research focused on understanding the nucleation mechanisms involved in various types of crystallization vessels. Dr Callahan’s previous work experience lies in continuous crystallization process development of APIs.