Route design and development

Evaluate whether the existing route and related steps meet the requirements of amplification, cost, safety and quality control

A doctor chemist with rich experience can suggest new synthetic routes and carry out laboratory exploration of new routes

Route exploration usually takes 2~3 steps/person week. The process chemist has the authority to operate LC-MS, GC-MS and other equipment, so as to quickly open up the route for subsequent process development

Quickly get through and optimize key steps through parallel reaction equipment

Apply new technology to make unacceptable steps acceptable

Rapid handling and production capacity of hazardous chemicals help route development and promote drug R&D progress

Process development and optimization

Fit for purpose process development and control strategy formulation

Completely carry out new drug IND research and support the application work

API process development and synthesis, supporting GLP TOX research and clinical research

Final process development for commercial production and supply

Process optimization to obtain robust process, reduce cost and improve output

High throughput screening and optimization of high cost catalysts

Salt type screening, crystal type screening, and then salt type crystal type characterization, selection and process development

API recrystallization process development and crystallization process optimization

Heterogeneous mass spectrometry analysis, impurity identification, synthesis and index setting

Application of online monitoring technology to guide process development, such as online infrared, online liquid phase, FBRM, etc

Apply QbD principles to guide process development, such as using DoE tools to conduct design space research

Capable of handling highly active compounds (OEL< 0.1 ug/m3)

Process safety test and evaluation (RC1, DSC, TGA, ARC, TSU)

Chemical engineering simulation capability supports process development (such as filtration rate simulation, oxygen content control assessment) and equipment risk assessment of project transfer (such as selection of kettle and paddle type, simulation and application of distillation parameters and azeotropic efficiency)