Methodology Report

Bioactivity Determination of Native and Variant Forms of Therapeutic Interferons

Figure 5

Test of the stability of the cell lines. Cells at three different stages (passage #15, 46, 51) were tested in this validation, which involved 3 replicates for each dose and in 3 replicate plates. Sample 1 was the in-house reference standard (a), with sample #2 and #3 being final drug products from syringes (b,c). Each sample was run in triplicate and tested on 3 different plates. The graphs represent the linear range of the tested doses as determined by comparison to the international reference standard.
174615.fig.005a
(a)
174615.fig.005b
(b)
174615.fig.005c
(c)