Development
Key capabilities at GlycoSyn are:
- Transition of gram-scale synthesis to kilo-scale manufacture
- Route and process optimisation to achieve robust, scaleable and efficient syntheses
- Analytical method development
- Reaction calorimetry for process safety
- Prototype kilo-scale manufacture to produce material for non-human toxicology and pre-clinical development
- Impurity analysis and interrogation
- Batch production documentation for regulatory compliance and complete product traceability
- Metabolite services
GlycoSyn offers safe, rapid and cost-effective scale-up of multi-step chemical processes. The PhD-qualified chemists and engineers in our process development division are highly skilled and have an international reputation for quality work.
They are supported by an equally strong analytical team which provides in-process control and final product method development expertise. These analytical methods are validated to meet ICH requirements for APIs in clinical development.
Prototype manufacture in GlycoSyn’s pilot laboratories provides drug substance for pre-clinical evaluation with full supporting documentation for subsequent clinical manufacture.
