Characterization of IXINITY® (Trenonacog Alfa), a Recombinant Factor IX with Primary Sequence Corresponding to the Threonine-148 Polymorph

Table 2

Functional characterization of trenonacog alfa.

	Lot 1	Lot 2	Lot 3	Lot 4	Lot 5	Lot 6	Mean	% RSD
Specific activity (IU/mg)	216	256	247	269	249	242	247	7.15
FIX activation rate (fraction FIXa band intensity^−1·minute^−1)	0.0182	0.0199	0.0157	0.0185	0.0171	0.0137	0.0172	12.9
Rate of increase in FIXa activity in presence of FVIIIa relative to absence of FVIIIa	1.79 × 10^3	1.85 × 10^3	1.75 × 10^3	1.65 × 10^3	1.90 × 10^3	1.82 × 10^3	1.79 × 10^3	4.86
Titration with AT; slope of inhibition curve (mIU FIXa·mL^−1·μM AT^−1)	−1.29 × 10^4	−1.53 × 10^4	−1.44 × 10^4	−1.81 × 10^4	−1.42 × 10^4	−1.44 × 10^4	−1.49 × 10^4	11.7