Services
Innogenetics Biologicals offers the following cGMP biomanufacturing services:
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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
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