Advanced analytical techniques
Eurofins CDMO offers advanced analytical services using state-of-the-art technology to support biologics development and validation, including:
Analytical development
Comprehensive suite of analytical techniques
To support biologics process development, Eurofins CDMO’s in-house R&D and GMP analytical teams provide a comprehensive suite of analytical techniques to ensure high quality and regulatory compliance.
- In-process control (IPC) during development
- Batch release testing
- Stability and forced degradation studies
- Photostability and material compatibility assessments
- Identity verification and process residual analysis
- GMP method validation
- Release & stability testing to support upstream processing
- Downstream process analytical testing
- Drug product characterisation
- Lifecycle management of analytical methods
R&D and GMP QC entities
Depending on the stage (process development versus GMP clinical batch manufacturing), Eurofins CDMO has an R&D analytical department as well as a GMP QC analytical department to support analytical requirements. At the appropriate moment and prior to GMP activities, the developed methods are pre-validated and transferred from the R&D environment to the GMP QC entity. The R&D pre-validation intends to:
- Demonstrate confidence in the methods for further usage in the R&D environment (e.g. for R&D accelerated stability studies)
- De-risk and facilitate the transfer of methods from our R&D entity to our GMP QC entity for subsequent validation, release and stability testing activities in a GMP environment, ensuring timelines are met
