Seamless transition from lab-scale to GMP-compliant manufacturing
Eurofins CDMO specializes in providing process development services to guarantee a seamless transition from lab-scale to GMP-compliant 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 and DSP services tailored to the specific needs of the biologic of interest.
Upstream process development
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. As an example, culture media formulations can be optimized and feed or harvest strategies finetuned. Before advancing the project to GMP cleanrooms, the USP process will be upscaled to confirm reproducibility of the process.
Downstream process development
Our downstream process development services are designed to purify and formulate your product to meet the highest standards of purity, potency, and quality. 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.
Analytical method 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.
- IPC analysis during process development and production
- Product characterization and non-GMP stability studies
- Quality by design (QbD) approach during the analytical life cycle
- Smooth transfer to GMP QC for DS and DP release
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Biochemical assays |
Biophysical assays |
Bio-assays |
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Gel electrophoresis (SDS-PAGE, WB) CE-SDS Chromatograpy (for product purity methods and for residuals testing methods)
High resolution mass spectrometry - Intact mass & peptide mapping Glycosylation profiling DNA quantification ELISA assays Endotoxin (LAL) testing Enzymatic activity assays HCP testing |
Interaction studies
Capillary electrophoresis cIEF Colorimetry pH Conductivity Osmometry Dynamic light scattering and zeta-potential DSF (Tm) Sub-visible particles (Flow imaging, LO) Protein aggregates and foreign particles (Flow imaging) Moisture (KF, water activity) |
Cell-based assays for neutralizing antibody assays or relative potency assay:
Microbial assays
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