Table 3: Relative potency of IFN-β as determined by RGA.

IFN-β samples (%)Mean estimated potencyRelative to assessment (%)Lower and upper limits (95% CI) (%)

8025875.986.8%79.4–94.9
10032462.7108.9%99.6–119.1
12034193.8114.7%104.9–125.5

The IFN-β samples were pre-determined by AVA, followed by spiking into media at 80, 100, and 120% of the expected values. The “spiked” samples were then subjected to RGA analyses in comparison with the reference standards.