Contract Manufacturing
Efficiency, traceability, reproducibility and flexibility.
Novozymes Biopharma operates a multi-purpose plant in Lund, Sweden. The equipment and product change-over procedures are validated according to cGMP. Production is performed in campaigns. The plant is authorised to handle recombinant and native microorganisms as well as moderate risk pathogens of class 2.
Characteristics of Novozymes Biopharma cGMP Production
- cGMP operations for biological API
- Integrated process development, up-scaling and manufacturing
- Supply of material for clinical studies as well as commercial use
- Process development and design, including microbial fermentation, recovery and purification
- Fed-batch, batch, continuous feed, from 20 to 5,000L
- Excellent track record in cGMP manufacturing
