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, Australiaand 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

Zuiderweg 72/2,
9744 AP Groningen,
Netherlands

Development offerings

Analytical development equipment
Assay examples
HPLC/UPLC based assay using both UV and fluorescent detectors
Size exclusion chromatography
Analytical proteinA chromatography
Ion exchange chromatography (CEX, AEX)
Glycan analysis
Peptide-mapping (UV)
96-384 well ELISA plate reader with UV/Vis and fluorescent detection
 
Product specific binding activity
Product identity
Impurities: HCP, ProteinA , Long IGF, total protein
Spectrophotometer (UV/Vis)
Solo VPE (UV/Vis)
Protein concentration
Capillary electrophoresis
Capillary isoelectric focusing (lce3)
R/NR CE-SOS
clEF for identity and purity
LAL reader (96 well) Endotoxins
OG reader Total organic carbon
Bioburden filtration setup Bioburden
FTIR Raw material ID testing

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