
DETAILS DESCRIPTION
Chemical R&D
- Position :
Our process chemists provide a broad range of services for drug substance development, ranging from route discovery, process improvement and optimization, process verification and scale-up, technology transfer from research to commercial scale, and multi-gram to multi-ton manufacturing of Active Pharmaceutical Ingredients (APIs) and intermediates in compliance to cGMP guidelines. Our relentless focus on providing innovative, flexible and cost-effective solutions will enable you to maximize your efficiency and shorten your lead times.
Process ROUTE Discovery AND SelecTION
• Discover and evaluate potential synthetic routes
• Carry out material and production cost analysis of each route
• Perform small-scale experiment to verify reliability of chemistry
• Make selection of route based on comprehensive parameters such as material cost, safety, engineering, and availability of material
PROCESS Improvement and OPTIMIZATIOn under qbd and DOE
• Process Optimization of key parameters such as reagent, catalyst, solvent, reaction temperatures and time
• Work-up conditions and material balance
SCALE UP robustness DEMONSTRATION
• Demonstrate the process on kilo scale
REACTION ENGINEERING and safety
• Isolation and crystallization studies such as solvent screening and selection and solubility study
• Impurity profile controlling such as impurity structure elucidation and impurity purge/fate
• Reference standard preparation
• Reaction safety assessment
• Stress parameter determination and scale up equipment selection
FACILITIES
Lab space: 50,000 SF
170 research fume hoods in Process lab
Low temp reaction capability: -80°C
Flow chemistry Set
Clean room for API production
© 2022 Gear Pharma Solutions Powered by: www.300.cn
Follow us via

