Route evaluation and selection
Optimization of key process parameters, and strategies for process control
Studies of polymorphs and final forms
API formulations
Synthesis of impurity markers and their fate and tolerance study
Control strategies for RSMs and intermediates; specifications for intermediate, and APIs
Analytical development & method validation
cGMP manufacturing at kilogram-scale
Lakestar has a strong technical team, and capable of transferring lab technologies to production seamlessly. We can carry out production at kilogram to hundreds metric ton scales. Lakestar has special technologies to carry out production on hydrogenation, cryogenic operation, and hazardous reactions, such as oxidation, nitration, diazotization, chlorination and bromination, etc.