Dr. Craig Callahan, Project Scientist, Cambrex Edinburgh, discusses the importance of understanding 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.
Our webinar discusses the deliverables of a crystallization process development work program and explains the tools available at Cambrex Edinburgh to achieve optimized drug substance particles.
This Cambrex webinar:
- Provides an introduction and overview of the importance of crystallization in the pharmaceutical industry
- Discusses the workflow of a crystallization process development program at Cambrex Edinburgh
- Considers examples of typical issues faced during the crystallization process development of an API
- Discusses 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 substances and drug products.
Watch the on-demand webinar - Understanding the importance of crystallization processes. Click here
Supporting materials
Peptide crystallization information sheet. Download here
Crystallization process development: Ramping up bench-scale control for manufacturing. Download here
Crystallization process development 2: Peptide crystallization. Download here