Bioactivity Determination of Native and Variant Forms of Therapeutic Interferons

Table 2

Relative potency determination of IFN variants compared with the reference standards.

	LL of estimated potency*	Estimated potency*	UL of estimated potency*	LL of relative potency (%)	Relative  potency (%)^#	UL of relative potency  (%)
Oxidized	2655720	20936900	26468300	61.30	77.50	98.00
Deaminated	22397100	28327600	35830700	83.00	104.90	132.70
Aggregated	33793	58875	99115	0.10	0.220	0.4

*:Actual reading of luciferase activity;
^#:Relative potency compared with the reference standards as determined by statistical analyses (bold face). The values in bold face refer to the relative potency of the samples with respect to the reference standards (EDQM IFN-α 2a). LL stands for lower limits of the 95% interval while UL denotes upper limits of the 95% interval.