 |
|
| |
Process Research
J-Star's management and staff have extensive experience in pharmaceutical process research that spans decades of practical hands-on expertise. Clients seeking to improve troublesome steps in a process, or redesign an entire route for one of their potential products or key intermediates, will find value added input at the chemistry level from the team at J-Star.
Our chemists can provide safe, cost effective and robust processes that are based on sound chemistry and valid analytical controls. This includes some of the following:
- Ensure the synthesis is suitable for long term, large scale manufacturing
- Optimize reagent charges, operating temperatures, concentrations, and work-ups
- Identify which steps can be combined to form a "through process"
- Optimize purification schemes by identifying key crystalline intermediates
- Optimize recrystallization parameters to ensure consistent high purity and low mother liquor losses
- Institute analytical controls for in-process assays, end of reaction specifications, intermediate and API purity.
Our two segregated, limited access cGMP suites are isolated from all other operations, contain dedicated HVAC, laboratory equipment, fume hoods and drying ovens. These suites are designed for production of material in gram to kilogram quantities. All production in these suites follow well defined standard operating procedures for handling all aspects of manufacture in these areas.
Back to Products
|
|
|
|
