GMP Cell Banking
Wacker Biotech holds certificates from the relevant authorities for its GMP-compliant production of cell banks. Our GMP facility in Jena provides a complete range of services for the manufacture, testing and storage of cell banks. Second storage site is available in Halle.
- Manufacturing of 250 – 300 vials / batch
- Separate compartment dedicated to GMP cell bank manufacturing only
- Dedicated storage room for GMP cell banks
- Long-term storage in -196 °C
Examples for release testing of the GMP cell banks:
- Optical density: OD600
- Purity: microbial contamination (bacteria, yeasts, molds)
- Bacteriophages by plaque assay
- Viability: living cell count
- Host strain identity: e.g. API20E (E. coli species) and strain-specific marker
- Plasmid identity: restriction pattern
- Expression test: SDS-PAGE and Coomassie staining