Table 1.

Product characteristics (attributes) and levels to create hypothetical FVIII product profiles

Attributes	Levels
Origin of FVIII	(1) FVIII made from human blood plasma
	(2) Plasma-free/recombinant (FVIII made completely in a laboratory with DNA technology)
Storage flexibility (temperature)	(1) Needs to be stored in the refrigerator at 2°C–8°C (~10 min until it reaches room temperature before you can inject it)
	(2) Can be stored anywhere outside the refrigerator at >25°C
	(3) Can be stored anywhere outside the refrigerator at >30°C
	(4) Can be stored anywhere outside the refrigerator at >40°C
Storage flexibility (shelf life): Maximum storage time at this temperature out of the refrigeratora	(1) Can be stored for ≤3 months
	(2) Can be stored for ≤6 months
	(3) Can be stored for ≤9 months
	(4) Can be stored for ≤12 months
Reconstitution device (mixing FVIII powder with solvent)	(1) Mix FVIII in a prefilled syringe with both powder and solvent enclosed in separate chambers of the same syringe
	(2) Mix FVIII powder with a solvent in a prefilled syringe. The syringe is connected with the vial containing FVIII
	(3) Mix FVIII with two connected vials. One vial contains FVIII powder, and the other contains solvent. Then put the mixed factor into a syringe connected with the vials
Stability out of refrigerator after mixing (in case of unexpected interruptions)	(1) 2 hours
	(2) 3 hours
	(3) 4 hours
Frequency of administration in prophylaxis	(1) 2×/week
	(2) 3×/week

Note:

^aShown only if Level 2, 3, or 4 is shown for attribute “storage flexibility (temperature)”.

Abbreviations: DNA, deoxyribonucleic acid; FVIII, factor VIII.