Our expertise

Eurofins CDMO offers expert process development services to ensure a smooth scale-up from lab to GMP manufacturing.

With our deep experience in GMP processes and adherence to Quality by Design (QbD) principles, we aim to deliver cost-effective, robust and high-quality solutions for our client’s projects, facilitating the supply of clinical materials for phase I and beyond.

Whether starting from scratch or refining existing processes, we deliver USP & DSP services tailored to the specific needs of the biologic of interest.

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Upstream processing

Eurofins CDMO offers scalable upstream process development to maximise yield and reproducibility for GMP manufacturing.

In upstream processing, we offer various options for high-density fermentation and cell culture. The process parameters are optimized in small-scale experimental design studies, allowing for rapid identification of optimal cultivation and expression yield conditions. Before advancing the project to GMP cleanrooms, the USP process will be upscaled to confirm reproducibility of the process.

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  • High-density fermentation and cell culture optimisation
  • Small-scale DOE studies to rapidly identify ideal process parameters
  • Media formulation, feeding and harvest strategies tailored to your biologic
  • Scalable validation to ensure reproducibility prior to GMP transfer
  • Expertise in high-yield fed-batch to maximise volume productivity and advanced perfusion processes for intensified, continuous manufacturing
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Downstream processing

Eurofins CDMO delivers integrated downstream process development to ensure high-purity, high-quality biologics ready for clinical use.

We employ a wide range of chromatography and filtration technologies, continuously updating and expanding our capabilities in this field.

Having drug substance and drug product services under one roof, the close collaboration between our formulation scientists and manufacturing teams has a synergistic impact on the DSP and (pre)formulation development activities.

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  • Advanced purification using a broad range of chromatography and filtration techniques
  • Continuous innovation and capability expansion in DSP technologies
  • Seamless collaboration between DSP, formulation and manufacturing teams
  • Integrated drug substance and drug product services for streamlined development
  • Purification experience from a wide range of feedstock 
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Analytical method development

Eurofins CDMO offers end-to-end analytical support to ensure product quality, consistency and regulatory compliance throughout development.

Our comprehensive portfolio of analytical competences covers biochemical and biophysical methods, as well as bioassays, ensuring the monitoring and characterization of critical attributes throughout the complete development process. Next to supporting process development, analytical methods are developed for batch characterization as well as stability studies. Selected methods can be qualified or validated in our GMP QC labs in view of product release and GMP stability testing of clinical materials.

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  • Biochemical, biophysical, and bioassay methods for critical quality attribute (CQA) monitoring
  • Method development for batch characterisation and stability studies
  • IPC testing during process development and manufacturing
  • QbD-driven analytical lifecycle management
  • Seamless transfer to GMP QC laboratories for drug substance and drug product release testing
  • Method qualification and validation for GMP stability and clinical material release
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Let's advance your innovation together

Contact your CDMO expert