Process Development
The network of Eurofins CDMO (Contract Development & Manufacturing Organization) companies has considerable experience with API process development, successfully introducing hundreds of chemical steps to cGMP scale up and advancing several APIs to commercialization.
Our development team performs Phase II support with the following services:
- Route or step rebuild
- Process optimization and demonstration
- Impurities assessment and synthesis
- Full Structure characterization and elucidation
- Analytical method development and qualification
- Stress studies and ICH stability studies
- CMC gap analysis for commercialization
To support API process development, we are able to use continuous flow technology with two technology platforms at your disposal: micro-chip based Chemtrix Labtrix™ and coil based Vapourtec™. This enabling technology is ideal for problematic syntheses and to address safety issues. A Kilotrix™ system is also available for cGMP scale-up. Our experts have made notable achievements such as a successful implementation of flow chemistry at lab scale to improve the efficiency of TMSI mediated deprotection of benzyl-protected ethers.
VAPOURTEC PLATFORM: ideal for customization
- Ability to customize unit for specific demands of the chemistry by adding pumps or reactors, or ability to “jury-rig” reactors to the unit
- Larger tubing avoids fouling of the lines
- Capable of supporting gram to kg scale reaction conditions depending on throughput
- 100’s of gram scale where there is adequate supply of starting material.
- Reactor volume of 10 ml to 100 ml, temperature range of ambient to 150°C, 42 bar maximum pressure
CHEMTRIX LABTRIX PLATFORM: ideal for reaction condition screening and scale-up synthesis
- Micro reactors allow for reaction condition screening using milligram scale material; ideal for screening trails using expensive starting materials
- Wide operating range (-20 to 195°C, 20 bar), low volume (< 50 mg for 100 data points), fast reaction screening (10’s to 100’s reactions per day), versatile reactor designs (T mixer, SOR mixer & Catalyst)
- Processes developed using the Chemtrix Labtrix®- S1 can be directly transferred to the Chemtrix KiloFlow® Basic for scale-up
