A Cambrex Webinar - Understanding the Importance of Crystallization Processes to Avoid Unnecessary Cost, Risk and Development Delays

Sponsored by Cambrex

June 8, 2020

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.

Cambrex Article Image

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