The cell culture process development group works closely with both downstream processing and manufacturing to ensure rapid development of scaleable clinical production processes which utilize either CHEF1 or other expression systems. This is made possible by using scale-down production models that incorporate animal-source-free media and platform "generic" processes. Process experience includes a variety of cell lines, expression systems, and production methods. Antibody expression levels of 2 g/L have been obtained using the CHEF1 system.
Our experience allows the
- Smooth transfer and scale-up of existing processes both into CMC Biologics and from CMC Biologics to commercial manufacturers
- Rapid process development from final clone selection through scale-up
- Cultivation in suspension and attached systems
- Serum and antibiotic free process development
- Adaptation to serum free formulations
- Bioreactor process development in 1L - 5L bioreactors
- Batch, Fed-batch and perfusion technologies
- Scale-up of transferred processes
- Batch, Fed-batch and perfusion up to 100L scale
- Strong expertise in all technologies with recognizable results in perfusion.
- CHO cultures running up to 100 x 106 viable cells/mL.
- GLP & cGMP Cell banking creation of RCB, MCB, WCB