Upstream Process Design
The Cellca fed-batch process platform was developed from scratch specifically to aid simple and efficient large scale GMP manufacturing of recombinant proteins. All process parameters, feeding regimen, and culture media are fully defined. The process is easily transferable and no complex steps such as, temperature or pH shifts, butyrate induction, feeding according to certain signals, etc. are required. The developed production processes exhibit all characteristics of a robust and industrial process design to:
- Reduce special hardware requirements
- Reduce daily adjustments
- Reduce human interaction
- Reduce requirement for experienced operators
- Reduce computer interaction
Our clients benefit from this unique Upstream Process Design during their development programmes, as all process development-related steps aim to provide a direct and robust scale-up of protein production processes to manufacturing scale. By this, costly and timely scalability studies are omitted, whereas development risks can be reduced and a faster time-to-clinic supported. Regardless whether you intend to transfer the manufacturing process of your candidate protein into stainless steel or single-use bioreactor systems, our fed-batch processes are compatible with both and our experienced technical staff support all process transfer activities.
We have a proven track record for directly scaling up fed-batch processes from 25 ml shake flasks through to 1000L SUB’s and STR bioreactors while maintaining product quality and achieving high fed-batch titres of 3 g/L or more (see figure 1).
Another example of the scalability and robustness of Cellca’s fed-batch process platform is demonstrated in the following graphic (see figure 2). We scaled the production process of an antibody producing cell line to different bioreactor volumes ranging from 50 L to 1000 L and conducted the process in different Sartorius bioreactor types.
Contact Cellca to find out more about our fast and easy scale-up process.