Flyer: API commercialisation
Eurofins CDMO works closely with clients to provide phase-appropriate solutions to balance any immediate and long-term API technology development and commercialisation needs.
The process is mapped with direction provided through risk assessment and design-of-experiment methodology. We are able to then examine impurities through targeted fate and purge studies to ensure clearance of impurities in order to achieve commercial approval of the client’s chosen API CMO.
Our state-of-the-art facilities go through multiple inspections and can be used for:
- Demonstration of optimised process to confirm yields, control impurities and control critical parameters
- Preparation and execution of process validation batches.