TABLE II

Combinations of Content and Median Size of Residual DNA Meeting Regulatory Safety Requirements

DNA Content (ng/dose)Median Size (bp)Relative Safety Margin
OncogenicityInfectivity
102001.001.00
10001201.0138.5
1001501.016.17
201456.9455.5
12452.801.03
0.1*3187.631.02
0.0145021.31.04
  • * Limit of 0.1 ng/dose or 100 pg/dose was the original WHO specification for DNA content.