Phase III
As the drug development program enters Phase III, Eurofins CDMO offers support in taking the molecule to market. Eurofins CDMO applies incremental development, which include the development and the optimization of processes, analytical development and enhanced control.
Our Capabilities Include:
- Fate & purge studies
- Impurities marker synthesis & qualification
- Design of experiments
- Critical process parameters studies
- Preparation for, and execution of process validation
- Continuing CMC support during & after-market launch
- Technology transfer to client’s API CMO, as applicable
- Drug Substance process upscaling with analytical support (Small Molecules / Biologics)
- Drug Product process upscaling with analytical support (Small Molecules / Biologics)
- Sterile and Non Sterile Manufacturing with analytical support
- Clinical Packaging and Logistics
