Process development

GTP proposes the development of fermentation, cultivation and purification processes for recombinant proteins.

We focus on developing cost-effective, robust and GMP conforming manufacturing solutions. In the case of therapeutics, we will ensure the seamless technical transfer of the developed process to your chosen cGMP manufacturer.

We have extensive experience in developping competitive protein production processes

Our equipment covers the range from laboratory bench scale to pilot and production scale.

Microbial cell culture:

  • organisms: E. coli, L. lactis, S. cerevisiae, P. pastoris
  • development of recombinant production strains, IP free vectors for E. coli
  • cell banking
  • development of microbial cultivation processes (batch, fed batch, chemostat, perfusion)
  • full documentation

Animal cell culture:

  • organisms: Mammalian cells (CHO & HEK derived cell lines), insect cells (Sf9, High 5, S2)
  • development of high-producing stable cell line. Learn more about our new CHO system.
  • adaptation of cell line to serum and/or protein free media and to suspension cultivation if needed
  • cell banking with GMP compliant release tests
  • development of culture process: medium screening and optimisation, optimisation of culture conditions, development of feeding strategies
  • full documentation

Purification process:

Process Development
  • Development of a robust purification scheme compatible with cost-effective large scale manufacturing:
    • Development of harvesting (centrifugation, deep filtration, TFF), cell lysis or medium concentration
    • Development of extraction and primary separation procedures, solubilization of inclusion bodies and refolding
    • Development of capture, purification and polishing steps (chromatography and filtration)
  • Development of analytical procedures for in-process and final product quality controls:
    • Methods for identification of protein (SDS-PAGE, capillary electrophoresis, western-blot, SE-HPLC, RP-HPLC, mass spectrometry, N-terminal sequencing, peptide mapping)
    • Methods for determination of purity and contaminants (Densitometric analysis on SDS-PAGE, HPLC, residual DNA, endotoxin level, host cell proteins)
    • Methods for quantification of protein (HPLC, Bradford, BCA, Elisa, activity test)
  • Formulation development
  • Full documentation
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