Bioactivity Determination of Native and Variant Forms of Therapeutic Interferons

Table 1

Matrix interference.

	LL of estimated potency	Estimated potency	UL estimated Potency	LL of relative potency  (%)	Relative potency	UL of relative potency
IL-2	0.962461	1.01024	1.06045	96.2	101.00	106.00
IL-6	0.929288	0.975531	1.02393	92.9	97.60	102.40
IL-1β	0.944126	0.991046	1.04024	94.4	99.10	104.00
TNFα	1.0784	1.13208	1.18928	107.8	113.20	118.90

The table shows data from one concentration of IL-2, IL-6, IL-1β, or TNF-α. Wider concentrations of IL-2, IL-6, IL-1β and TNF-α found no interference with our assay (not shown in the table). The tested ranges are the following: IL-2: 200–2000 IU/mL; IL-6: 200–2000 IU/mL; IL-1β: 40–400 U/mL; TNF-α: 100–1000 ng/mL. The values in bold face represent relative potency compared with the reference standards as determined by statistical analyses. LL stands for lower limits of the 95% interval while UL denotes upper limits of the 95% interval.