Impurity Assessment
| DNA Genome | ||||||||
|---|---|---|---|---|---|---|---|---|
| CTO | Protein (μg/mL) | Protein (pg/PFU) | dsDNA (μg/mL) | dsDNA (pg/PFU) | Aggregates (%) | Titer Loss (log10) | ||
| MMV | a | 95 | 3.30 | 43.88 | 0.152 | 88.38 | 0.93 | |
| b | 2841 | 286.97 | 19.18 | 0.194 | 56.01 | 0.36 | ||
| d | 463 | 3.31 | 47.61 | 0.034 | 79.68 | 0.69 | ||
| e | 17 | 4.25 | 1.79 | 0.045 | 71.66 | 0.55 | ||
| PPV | a | 96 | 0.09 | 38.08 | 0.003 | 24.96 | 0.12 | |
| b | 2596 | 136.63 | 60.84 | 0.320 | 36.17 | 0.20 | ||
| c | 858 | 45.40 | 14.51 | 0.077 | 63.06 | 0.43 | ||
| d | 952 | 25.73 | 40.37 | 0.011 | 56.66 | 0.36 | ||
| e | 81 | 0.99 | 1.95 | 0.002 | 69.45 | 0.52 | ||
| PRV | a | 5208 | 2170.00 | 1.84 | 0.077 | 86.42 | 0.87 | |
| d | 429 | 98.17 | 27.17 | 0.622 | 81.35 | 0.73 | ||
| RNA Genome | ||||||||
|---|---|---|---|---|---|---|---|---|
| CTO | Protein (μg/mL) | Protein (pg/PFU) | dsDNA (μg/mL) | dsDNA (pg/PFU) | Aggregates (%) | Titer Loss (log10) | ||
| MuLV | a | 5850 | 1063.64 | 61.12 | 1.111 | 85.96 | 0.85 | |
| b | 64872 | 7911.22 | 38.45 | 0.938 | 46.77 | 0.27 | ||
| d | 969 | 293.64 | 27.26 | 0.826 | 48.49 | 0.29 | ||
| Pol | a1 | 104 | 0.30 | 67.09 | 0.019 | nd | nd | |
| a2 | 52 | 0.52 | 28.07 | 0.028 | nd | nd | ||
| Reo-3 | d1 | 238 | 24.04 | 28.51 | 0.288 | 74.62 | 0.60 | |
| d2 | 502 | 63.54 | 30.50 | 0.386 | 75.66 | 0.61 | ||
| Summary | |||
|---|---|---|---|
| Virus | Prot/pfu | dsDNA/pfu | Aggregates |
| MMV | a∼d∼e<<b | d∼e<a∼b | b<e∼d<a |
| PPV | a<e<d<c<<<b | e∼a<<c∼d<<<b | a<b∼d∼c∼e |
| PRV | d<<<a | a<<<d | a∼d |
| MuLV | d<a<<b | d∼b∼a | b∼d<a |
| Pol | a1<a2 | a1∼a2 | |
| Reo-3 | d1<d2 | d1∼d2 | d1∼d2 |
Refer to Table II for CTO/source-certified titer values.
Top: Virus preparation protein, exogenous double-stranded DNA (dsDNA), and aggregate content for viruses that contain a single-stranded (MMV, PPV) or double-stranded (PRV) DNA genome. Protein and dsDNA content (expressed as μg/mL) were adjusted with respect to CTO/source-certified titer and expressed as pg/PFU. Aggregate content was expressed as a percentage (%) and as a logarithmic loss of titer (log10). Middle: Virus preparation protein, dsDNA, and aggregate content for viruses that contain a single-stranded (MuLV) or double-stranded (Reo-3) RNA genome. Bottom: Summary of results, rank-ordered from lowest to highest, where lower values may be more desirable.