Table 4. Lot-to-lot variation of Sigma V.

Data are expressed as mean ± SD and analyzed by one-way ANOVA. IEq=islet equivalent. SI=stimulation index. Multiple comparisons using ANOVA were considered significant at p<0.01.

Variables	Lot A: 077K8628	Lot B: 047K7681	Lot C: 077K8629	Lot D: 026K8640	P value
N	24	10	6	6
Pancreas weight(g)	95.13 ± 28.01	99 ± 20.27	90.66 ± 19.36	114.00± 44.24	0.294
Digestion time(m)	15,22 ± 2.76	15,11 ± 5.63	12.83 ± 2.73	14.20 ± 1.30	0.172
Digestion percentage (%)	65.47 ± 16.95	53.66 ± 25.97	62.66 ± 27.77	69.17 ± 13.14	0.222
Pre-purification IEq	3621366.6 ± 173610.8	232418 ± 138778.2	202285.5 ± 120189.2	317356.3 ± 66904.6	0.084
Post-purification IEq	248662.9 ± 133587.4	220136.5 ± 129539.8	205890.3 ± 138822.7	278854.5 ± 161982.1	0.645
Purity of post-purification (%)	83.76 ± 12.65	76.25 ± 20.48	87.5 ± 7.07	78.33 ± 15.06	0.441
Purification recovery rate (%)	68.82 ± 23.82	77.37 ± 22.40	88.16 ± 10.64	97.83 ± 75.22	0.179
IEq /gram pre-purification	4048.13 ± 2031.83	2108 ± 1045.1	2247.67 ± 1102.53	3229.29 ± 1603.03	0.067
IEq/gram post-purification	2782.21 ± 1535.32	2096.57 ± 1311.85	2306.33 ± 1454.03	2701.24 ± 1743.10	0.751
SI	4.18 ± 4.34	2.81 ± 1.71	2.09 ± 1.09	3.42 ± 1.28	0.465
Viability (%)	93.31 ± 4.84	93.88 ± 2.20	91.25 ± 2.96	93.27 ± 5.06	0.467
Endotoxin (EU/ml)	0.020 ± 0.03	0.016 ± 0.01	0.015 ± 0.01	0.02 ± 0.01	0.749
Quality score	5.58±1.63	6.38 ±1.74	5.63±1.48	6.72±1.69	0.091