A Biotechnological process starts with vials of the cell bank, and includes cell culture, harvest, purification and modification reactions, filling, storage and shipping.
The production process of Biologics is influenced by many different process parameters. Biotechnological processes are variable as such, but also the raw materials used influence reproducibility and quality. Furthermore, results of testing methods are prone to variability.
To overcome variabilities, it is important to Optimise your process as much as possible. Thereafter, designing Process Validations, including understanding of the regulatory expectations, is key.
We help you to Control your Biological Process!
- Cell Banking
- Raw Materials Testing
- Process Optimization
- Spent Media
- Process Control
- Process Related Impurities
If you want to discuss your project or request a quotation, feel free to contact us.