Table 1.
Manufacturing processes for which sampled manufacturers require support.
| Assessed manufacturing processes | Number of manufacturers requiring support | Percentage |
|---|---|---|
| Drug Substance | ||
| Scale-up | 20 | 74.1% |
| Upstream processes | 19 | 70.4% |
| Downstream processes | 19 | 70.4% |
| Facility modification | 11 | 40.7% |
| Drug Product | ||
| Formulation | 18 | 66.7% |
| Filling | 10 | 37.0% |
| Packaging | 3 | 11.1% |
| Storage | 2 | 7.4% |
| Supply | ||
| Shipping Validation | 12 | 44.4% |
| Cold chain equipment | 8 | 29.6% |
| Logistics | 4 | 14.8% |
| Clinical Trials | ||
| Phase III | 19 | 70.4% |
| Protocols Development | 13 | 48.1% |
| Phase I | 11 | 40.7% |
| Phase II | 11 | 40.7% |
| Post-marketing Surveillance | 9 | 33.3% |
| Contract Research Organizations | 5 | 18.5% |
| Regulatory | ||
| Guidance on EUA | 16 | 59.3% |
| PQ | 16 | 59.3% |
| Collaborative Registration Procedure | 14 | 51.9% |
| Post Approval Changes | 7 | 25.9% |
The number and percentage of sampled manufacturers who require support for the listed processes.
Respondents were able to select any number of the listed processes.