Table 1.

Potency and specific activity of FVIII in pharmacologic products

Product/lot	Potencya U/ml	FVIII conc.b nM	APTTc		FXasec
			Potency U/ml	Specific activityd U/mg	Potency U/ml	Specific activityd U/mg
rFVIII standard	3,100	2,175	3,100	5,000	3,100	5,000
Product A (contains full-length rFVIII)
2938A540AC	200	88	190	7,600	192	7,700
2938C509AB	200	76	190	8,700	186	8,600
2938C828AA	200	86	200	8,200	200	8,200
Average:	200	83	193	8,200±500	193	8,200±400
Product B (contains full-length rFVIII)
BXNOL9P	100	30	75	8,800	98	11,500
BXNOL7G	200	180	200	3,900	208	4,100
GAWSF1	400	230	460	7,000	388	5,900
Average:	230	150	245	6,600±2,000	231	7,200±3,200
Product C (contains plasma FVIII)
2935B054EA	200	105	200	6,600	136	4,500
2935B044EA	200	80	170	7,500	128	5,600
2935Y004EB	200	85	160	6,600	128	5,300
Average:	200	90	180	6,900±400	131	5,100±500
Product D (contains plasma FVIII)
09H3901I	100	106	140	4,600	96	3,200
09H3702K	100	100	115	4,000	104	3,600
09H4401K	100	103	140	4,800	96	3,300
Average:	100	103	132	4,500±300	99	3,400±200
Product E (contains truncated rFVIII)
77269	200	95	160	9,600	192	11,900
80431	200	85	170	11,400	202	14,000
80354	200	89	166	10,600	200	13,200
Average:	200	90	165	10,500±700	198	13,000±900

^aProvided by manufacturers;

^bDetermined by ELISA;

^cDetermined in the current study;

^dCalculated using MW of 285 kDa for rFVIII standard and products A-D and 170 kDa for product E.