Drug Substance Manufacturing - Microbial Fermentation
Products
Information
Clinical and commercial supply services from our facility in Vienna/Austria.
Product Track Record: 20 microbial biopharmaceuticals brought to the market together with our partners.
Service description:
- 12,000 L overall commercial manufacturing capacity in multi-licensed facility
- Two trains each with 6,000 L of capacity which can be used with flexible scales including commercial large-scale HPLC in explosion proof units
- Large-scale GMP facilities licensed by EMA, FDA & MHLW and other authorities for clinical and commercial global supplies
- Protein refolding, chemical modifications to prolong molecule half-life and purification-only for all kind of recombinant proteins from microbial technologies
- Several plasmid-based gene expression systems for E. coli and Yeast
- Process and analytical development
- GMP batch release testing
- Manufacturing of e.g., Fab fragment, peptide hormones, plasmid DNA, scaffolds, recombinant proteins, enzymes and recombinant vaccines like VLPs
