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Testing Requirements for the Release of Recombinant Hepatitis B Vaccine
| Type of test | Stage of production |
|---|---|
| Plasmid retention | Fermentation production |
| Purity and identity | Bulk-adsorbed product or nonadsorbed bulk product |
| Sterility | Final bulk product |
| Sterility | Final container |
| General safety | Final container |
| Pyrogen | Final container |
| Purity | Final container |
| Potency | Final container |
