Your chemical processes are safe in our hands.
GlycoSyn’s Process Development division focuses on the safe, rapid and cost-effective scale-up of multi-step chemical processes.
Our highly skilled development scientists work to optimize the processes for manufacturing your API. We also conduct pilot-scale manufacture, so that you have the amount of API you need for pre-clinical evaluation, and the full supporting documentation for regulatory submission to facilitate subsequent clinical manufacture. Our equally strong analytical team supports process development with its in-process control and final product method development expertise.
What we Offer:
- Transition of gram-scale synthesis to kilo-scale manufacture
- Route and process optimisation for robust, efficient, scale-up syntheses
- Analytical method development
- Pilot kilo-scale manufacture for pre-clinical development
- Batch production documentation for regulatory compliance and complete product traceability
- Reaction calorimetry for process safety
- Impurity analysis
- 5 - 75 L jacketed lab reactors (−80°C to +150°C)
- UPLC, HPLC with UV, MS, CAD detection
- Parallel reaction screening equipment
- Crystallization screening/characterization
- Automated chromatography
- Design of experiments (DoE)
"Our late-stage development processes are well engineered for product, process and personal safety. We make sure we fully understand the often highly reactive pharmaceutical materials that we are dealing with, and have adequate engineering in place to handle them before we move to large-scale manufacture. GlycoSyn’s GMP production business and quality system focus makes it unique in the Australasian development space.”
Dr. Graham Gaygill, Senior Chemist and Chemical Engineer, GlycoSyn