Table 5.
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.