Table 3.
Key Assumptions for the Alternative Batch, Continuous, and Hybrid Manufacturing Strategies
| Variable | Values | |
|---|---|---|
| Clinical Trial Estimates | ||
| Non‐human primate dosage (mg/kg body weight) | 700 | |
| Non‐human primate in Pre‐Clinical trial | 100 | |
| Patient dosage (mg/kg body weight) | 7 | |
| Number of doses per patient per year | 26 | |
| Individuals in Phase I clinical trials (single dose) | 40 | |
| Individuals in Phase II clinical trials (6 month dose) | 200 | |
| Individuals in Phase III clinical trials (year dose) | 2,000 | |
| USP Process Parameters | Fed‐batch | ATF |
| Cell culture time (days) | 12 | 28 |
| Harvest volumes | 1 | 20 |
| Max VCD (million cells/mL) | 10 | 50 |
| Max bioreactor volume (L) | 20,000 | 1,500 |
| Annual number of batches | 20 | 10 |
| DSP Process Parameters | Batch | PCC |
| Binding capacity (g/L) | 40 | 65 |
| Bed height (m) | 0.25 | 0.1 |
| Number of columns | 1 | 3 |
| Shift duration (hours) | 12 | 24 |
| Cost Parameters | ||
| QCQA batch release costs ($/batch) | 35,000 | |
| Media cost ($/L) | 3.1 | |
| Protein A resin cost ($/L) | 8,000 | |
| AEX resin cost ($/L) | 1,500 | |
| Virus retention filtration membrane ($/m2) | 3,250 | |
| Labour cost ($/h) | 58 | |
| Chromatography process skid (15–600 L/h) ($) | 226,000 | |
| PCC process skid (15–600 L/h) ($) | 1,080,000 | |
| Chromatography column (Dia = 0.2 m) ($) | 132,000 | |
| Chromatography column (Dia = 2 m) ($) | 218,000 | |
Note: USP refers to upstream processing, DSP to downstream processing.