Table 5.
Lot Release Assays and Specifications for the Recombinant Vesicular Stomatitis Virus Clinical Lot
| Assay | Specification | Results |
|---|---|---|
| In vitro viral assay (parallel culture) | Negative | Negative |
| In vitro viral assay (unprocessed bulk) | Negative | Negative |
| Mycoplasma (PTC) | Negative | Negative |
| Residual host DNA | Report result | 64.03 fg/μl |
| Size distribution of residual DNA | <500 bp | Pass |
| Residual Benzonase by ELISA | <100 ng/ml | <1 ng/ml |
| Vector ID (RT-PCR) | Match expected size | Pass |
| LAL—endotoxin | <10 EU/ml | Pass |
| Viral particle counts by TEM | Report result | 1.6 × 1011 particles/ml |
| Sterility assay (USP) | Negative | Negative |
| B&F—Qualification of sterility testing | Pass | Pass |
| Infectious titer | Report result | 1.7 × 1010 PFU/ml |
B&F, Bacteriostasis and Fungistasis; LAL, Limulus amebocyte lysate; PTC, Points to Consider; TEM, transmission electron microscopy; USP, U.S. Pharmacopoeia.