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Services

Innogenetics Biologicals offers the following cGMP biomanufacturing services:

Process development (fermentation/cell culture) and upscaling:

  • Batch fermentation
  • Fed-batch fermentation
  • Perfusion
  • Anchorage-dependent and suspension cell lines
Purification process development and upscaling:
  • Recombinant proteins
  • Viruses
  • Plasmid DNA
  • Monoclonal antibodies
  • Microbial and eukaryotic cells

Formulation development

Analytical method development:

  • Biochemical and biophysical methods
  • Potency assays
Production of Master and Working Cell Banks, including BL-2 cell lines and strains

Production of Master and Working Virus Seeds, including BL-2 viruses

Up to large-scale production of proteins in microbial systems such as:
  • E. coli, H. polymorpha, P. pastoris, S. cerevisiae
  • BL-2 strains
Up to large-scale production of proteins in a wide variety of eukaryotic cells such as:
  • Insect cells
  • Mammalian and human cells
Production of (recombinant) viruses including BL-2 class viruses to large scale

Formulation and filling activities including BL-2 products such as:
  • Viruses
  • Microbial and eukaryotic cells
  • Proteins
Final QC of Drug Substance and Drug Product:
  • Biochemical and biophysical tests
  • Potency assays
Storage of produced:
  • Master and Working Cell Banks
  • Master and Working Virus Seeds
  • Drug Substance and Drug Product
Stability studies:
  • Master and Working Cell Banks
  • Master and Working Virus Seeds
  • Drug Substance
  • Drug Product

 

Operator BMU

 

 

 

 

 

 

 

Drug Product