Upstream processing (USP)
Eurofins CDMO offers scalable upstream process development to maximize yield and reproducibility for GMP manufacturing.
Process development
Our expertise
- 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 maximize volume productivity and advanced perfusion processes for intensified, continuous manufacturing
Downstream processing (DSP)
Eurofins CDMO delivers integrated downstream process development to ensure high-purity, high-quality biologics ready for clinical use.
- 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
Analytical method development
Eurofins CDMO delivers integrated downstream process development to ensure high-purity, high-quality biologics ready for clinical use.
- 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
