Groningen
Biologic manufacturing of mammalian cell cultures, recombinant proteins and monoclonal antibodies
Groningen, Netherlands
Thermo Fisher’s Groningen facility specializes in cGMP for (pre)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, Hangzhou, China and St. Louis, Missouri, USA.
Specialized capabilities
- cGMP manufacturing for early and late clinical and commercial supply, including process validation and PPQ
- Over 6 years (>70 batches produced) commercial manufacturing experience
- Wide range of single-use technologies
- Modular set-up to match process needs
- Experience in Fed Batch, Perfusion, n-1 Perfusion, and XD® processes
- Experience with all commercial cell lines
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 |
Helpful Resources
Infographic
Infographic
CDMO Checklist to Launch Your Molecule Globally
Preparing to take your drug into the global market? You’ll need to make sure your CDMO has what it takes to successfully navigate the global regulatory space with speed, security, and supply safeguards. Use this quick list as a reference when evaluating your options.
View Infographic
Webinar
Webinar
Navigating the EU regulatory landscape: Accelerating drug development, treatment innovation and market access
During this three-part webinar series, we cover key areas sponsors must be mindful of during drug development in preparation for filing successful regulators submissions.
Watch Webinar
Infographic
Infographic
Getting your biologic to IMPD faster in EMEA
This infographic provides insight into how to balance speed, risk and future needs so as to accelerate your biologic discovery to market in Europe.
Infographic
Infographic
A practical guide to writing robust chemistry, manufacturing, and controls dossier modules to support first-in-human trials
Do you need to get your first-in-human (FIH) paperwork in order? This informative checklist can help you draft phase-appropriate chemistry, manufacturing, and controls (CMC) modules for the common technical document (CTD).