95% right-first-time (RFT) biologic
batch completion (2025)
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Groningen
Biologic manufacturing of mammalian cell cultures, recombinant proteins and monoclonal antibodies
Over 220 biologic batches ranging from Phase I clinical to commercial manufacturing (2018-2025)
25 technology transfers successfully completed (2020-2025)
French CIR (Crédit d'Impôt Recherche) certified, enabling partners to benefit from tax incentives
Thermo Fisher’s Groningen facility specializes in cGMP for clinical and commercial manufacturing, including mammalian cell culture manufacturing, scale up and cGMP manufacturing of recombinant proteins and monoclonal antibodies. The site leverages decades of expertise in manufacturing, and has a strong regulatory and inspection history, since 1994.
Supporting the growth and development in the biotech drug substance market, and to meet clients’ needs, Groningen has recently expanded its cleanroom area by 29%.
Groningen is part of our European network of biologics sites, which includes Lengnau, Switzerland and part of our Global network including Brisbane, Australia, and St. Louis, Missouri, USA.
Proven track record for success
- 77 clinical (Phase I – III) batches completed (2020-2025)
- 6 PPQ batches (2020-2025)
- 2 PPQ series (2020-2025)
- 48 commercial batches (2020-2025)
Specialized capabilities
- cGMP manufacturing for early and late clinical and commercial supply, including process validation and PPQ
- Experience in Fed Batch, including N-1 perfusion and perfusion processes
- Experience with all commercial cell lines
- Wide range of single-use technologies
- Modular set-up to match process needs
- In house quality control, quality assurance, and regulatory affairs
Development offerings
| HPLC/UPLC based assay using both UV and fluorescent detectors |
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| 96-384 well ELISA plate reader with UV/Vis and fluorescent detection |
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| Spectrophotometer (UV/Vis) Solo VPE (UV/Vis) |
Protein concentration | |||||
| Capillary electrophoresis Capillary isoelectric focusing (lce3) |
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| LAL reader (96 well) | Endotoxins | |||||
| OG reader | Total organic carbon | |||||
| Bioburden filtration setup | Bioburden | |||||
| FTIR | Raw material ID testing |