- N-1 perfusion in Rocking Motion (RM) and WAVE bioreactors :
Using perfusion in N-1 seed expansion is widely used in the industry to realize process intensification and different modes of the production culture. Using a rocking bioreactor for N-1 perfusion process has additional benefit over a stirred-tank reactor coupled with a cell retention device.
- Reducing the use of disposable stirred tank reactors in the seed train.
- Supporting the high seeding density in fed-batch and perfusion cultures.
- N-1 perfusion provides a high transfer cell density to support inoculation of production bioreactors at different scales, thus a wide range of seeding density can be realized.
- PAT: implementation of Raman spectroscopy for automatic control in pilot scale production
Raman spectroscopy offers non-destructive, continuous, real-time measurements to monitor the performance during cell culture, thus providing a good PAT tool for biologics manufacturing. At the NPP, multiple case studies have demonstrated that Raman spectroscopy can be utilized together with existing bioreactor controllers to realize automatic control of a perfusion culture.
Automatic control of VCD stably at 40 × 106 cells/mL in a 45-day perfusion culture, at 50 – 150 L culture volume;
Precise and easy-to-operate process in combination with one-point calibration of Delta V controller system.
- This case demonstrated that with a Raman spectroscopy probe, the VCD of a perfusion culture can be automatically maintained and remain stable at 40 e6 for up to 35 days.
- In-line dilution with ÄKTA
In-line dilution with ÄKTA is widely used in the biopharmaceutical industry, to enable easier purification processes and buffer preparation and improve efficiency.
This technology can also help to improve capacity, realize cost saving and easier buffer delivery.
- to reduce the demand of disposable bags and tanks in buffer preparation
- to reduce the space for buffer storage
- less buffer filtration time