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Batch Operational Risk for the Alternative Batch, Continuous, and Hybrid Manufacturing Strategies
| Manufacturing Strategies | USP Risk | DSP Risk | Overall Risk Score |
|---|---|---|---|
| Base case | 1% | 0.2% | 1.2% |
| FB‐CB | 1% | 0.3% | 1.3% |
| ATF‐CB | 2.8% | 2.3% | 5.1% |
| FB‐CC | 1% | 1% | 2% |
| ATF‐CC | 2.8% | 4.6% | 7.4% |
