Christina Dooley, Technical Services, Ireland

Small-scale cGMP manufacturing

With the flexibility to support small clinical and commercial batches, or scale to commercial volumes, our cGMP pilot facilities are ready to grow with your API demand. 

Our team of analytical chemists and engineers are experts at developing and trouble-shooting analytical methods. 

Capabilities at a glance

Small Molecule APIs

  • Full development of synthetic route
  • Raw material analysis
  • Process safety
  • Process optimization
  • Scale-up from lab to pilot to commercial
  • Full development of analytical methods
  • Impurity assessment, fate and purge studies
  • Characterization of API
  • Specification development
  • Clinical manufacturing Ph I - III
  • Optimization of cell cultures and lab-based fermentation processes
  • Plant scale fermentation development
  • Regulatory support – pre and post-launch