Combinations of Content and Median Size of Residual DNA Meeting Regulatory Safety Requirements
DNA Content (ng/dose) | Median Size (bp) | Relative Safety Margin | |
---|---|---|---|
Oncogenicity | Infectivity | ||
10 | 200 | 1.00 | 1.00 |
1000 | 120 | 1.01 | 38.5 |
100 | 150 | 1.01 | 6.17 |
20 | 145 | 6.94 | 55.5 |
1 | 245 | 2.80 | 1.03 |
0.1* | 318 | 7.63 | 1.02 |
0.01 | 450 | 21.3 | 1.04 |
↵* Limit of 0.1 ng/dose or 100 pg/dose was the original WHO specification for DNA content.