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.

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Advanced analytical techniques

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  • 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
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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:

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  • 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