Biotechnological GMP Production of Proteins

For the production of recombinant proteins, Glycotope Biotechnology has focussed on mammalian and insect cell expression systems. Our core competences are centered on development and production of glycoproteins and antibodies.

Glycotope Biotechnology covers the complete process development starting from a research cell line up to the GMP production of recombinant proteins in multi-gram scale as active pharmaceutical ingredients (API).

Based on the core technology of Glycotope GmbH, Berlin, we are able to express and purify pharmaceutical proteins and antibodies in human cell lines with optimized glycosylation patterns.

Cell Line Development

  • Adaptation of cell lines to serum free media
  • Conversion of adherent growing cells into suspension cell lines
  • Optimisation of gycosylation pattern
  • Master Cell Bank (MCB) and Working Cell Bank (WCB) generation and characterisation


Development of Downstream Processing

  • Method development for protein capturing from harvest
  • Scouting for convenient liquid chromatography methods (IEC, SEC, HIC, RP, Affinity)
  • Optimisation of purification schemes taking advantage of the AEKTA™ LC platforms
  • Removal of host cell protein (HCP), endotoxins and host cell DNA as critical impurities
  • Evaluation of robust virus removal steps


Cell Fermentation

  • Stirred tank vessels for suspension cells equipped with cell retention units for perfusion fermentation
  • Wave reactors
  • Fixed fibrous bed (Celligen and customized system)
  • Fluidized bed (Celonics)
  • Multi-tray technology
  • Roller bottle in large scale
Our production capacity by fed batch fermentation, continuous culturing in perfusion (using cell retention systems) are yielding up to 5.000 L harvest per batch and GMP module, i.e. multiple grams of protein per day. Four equivalent GMP modules can be operated in parallel.

Cell cultivation processes are performed in routinely monitored clean rooms corresponding to ISO class 8 (grade D).


Downstream Processing

  • Cell removal
  • Buffer exchange and product concentration by ultra-filtration
  • Column chromatography (i.e., IEC, SEC, HIC, RP, Affinity)
  • Robust virus removal steps

Chromatography can be performed up to production scale. Purification of cell-free harvest is performed in routinely monitored clean rooms corresponding to ISO class 7 (grade C).

Final filling of API is performed in a clean room with level "A in B" standard

Product Release and Documentation

  • Analytical testing of final API-product
  • Certificate of analysis
  • Stability studies
  • CMC or CTD, as required
The batch release is performed by the Qualified Person after inspection of whole documents.


Support and Information

For more information please contact us at biotech@glycotope-bt.com or ask our experts.

Contact and information documents can be downloaded here...