Table 1 specified scale-up parameters and defined protein characteristics
scale-up parameter | protein characteristics | |||
|---|---|---|---|---|
Parameter | Design Space | 300L GMP | specifications defined at the project start | 300L GMP |
Mixing Time [s] | 10 - 70 | max. 60 | Isoforms (IEF) | pH 7.6 - 8.8 |
Tip-Speed [m/s] | 0.6 - 1.2 | max. 1.0 | Glycosylation (HPAEC-PAD) | Mol% of different forms ± 20% from clone screening |
Reynolds Number | 1 - 8 Mio | max. 6 Mio | Potency | 40% - 160% from clone screening |
Power Input [W/m3] | 25 - 1100 | max. 650 | Molecular weight (SDS-PAGE) | Main Band at app. 150 kDa |
Gassing | Head Space / Ring Sparger | Head Space & Ring Sparger | Immunogenic glycostructures | none |
Agitation | orbital sh., Rushton I. | Rushton I. | Purity (HP-SEC) | > 90% |