Table 2.

LLOQ determination

Donor/peptide combination	Donor ID	Peptide stimulus	Mean SFU/wella	No. runs with CV ≤30%
1	Donor 4	CMVpp65b	221.5	6
2	Donor 1	FVIIIc pool 2	82.2	6
3	Donor 1	FVIII pool 3	75.1	6
4	Donor 4	FVIII pool 4	44.4	6
5	Donor 5	FVIII pool 4	41.8	0
6	Donor 4	FVIII pool 2	39.3	3
7	Donor 5	FVIII pool 2	37.7	0
8	Donor 5	FVIII pool 1	33.2	1
9	Donor 2	FVIII pool 2	<LOD	N/A
10	Donor 2	CMVpp65	<OD	N/A
11	Donor 3	FVIII pool 2	<LOD	N/A
12	Donor 3	CMVpp65	<LOD	N/A
13	Donor 6	FVIII pool 2	<LOD	N/A
14	Donor 6	CMVpp65	<LOD	N/A

Bold indicates values selected as LLOQ.

^aCell-plating density was 200,000 PBMCs/well and viability was ≥70% for all donor samples across all runs.

^bCMVpp65, 65 kDa phosphoprotein of cytomegalovirus.

^cFVIII, transgene product.