Our services
To support the process development of your biologic, the Eurofins CDMO in-house R&D and GMP analytical departments offer a versatile toolbox of analytical techniques to ensure exceptional quality and regulatory compliance.
Advanced Analytical Techniques
At Eurofins CDMO, we pride ourselves on our cutting-edge analytical capabilities. Our laboratory is outfitted with the latest technology to perform a wide array of precise analyses for analytical development and validation.
Our services by means of this toolbox include:
• Hands-on in-process-control (IPC) support during development processes of biologics.
• Release testing of batches
• Stability studies
• Forced degradation studies and Photostability
• Material compatibility studies
• Profound scientific investigations to ensure the correct identity of the biologic
• Process residual analyses
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 take care of the analytical work. 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 has several intentions:
- Demonstrating confidence in the methods for further usage in the R&D environment (e.g. for R&D accelerated stability studies)
- De-risking and facilitating 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
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