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GMP Recombinant Protein Manufacturing

Eurogentec produces GMP recombinant proteins according to the most appropriated expression strategy including refolding of inclusion bodies, selective periplasmic expression, secreted into the media or soluble cytoplasmic.

We offer a highly flexible approach allowing us to start from your electronic sequence, research cell-bank or GMP cell-bank*.

Once the stable cell line is established we can start the process development following the FastTrack or OptiTrack method, both offering GMP material suitable for clinical trials. The FastTrack process focuses on the delivery of GMP material in the shortest amount of time while the OptiTrack focuses on the delivery of GMP material with the highest yield. *In case of an electronic sequence, Eurogentec will perform cell line development according to your expression strategy or multiple cell lines to identify the highest producer of recombinant protein in the best quality.

Service Overview

  • Cell line development
  • Fermentation, purification and QC development
  • Process scale-up
  • Production of Tox and clinical batches
  • Fill & Finish, Packaging, Labelling

Eurogentec offers

  • Manufacturing with all the important microbial strains (E. coli, P. pastoris, H. polymorpha, S. cerevisiae, Biosafety level 2 micro-organisms that are non-sporulating)
  • Off-patent Pichia Pastoris systems
  • Production experience with enzymes, cytokines, antibody fragments, fusion proteins, scaffolds, and more

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