Table 4

Manufacturing success rate and results from 75 PHPI lots by facility and for all facilities

Center ID
1 (n = 9)2 (n = 4)3 (n = 17)4 (n = 15)5 (n = 7)6 (n = 12)7 (n = 6)8 (n = 5)All facilities (N = 75)
All CIT isolations*
 No. lots prepared5727443935581937324
 PHPI lots transplanted29 (50.9)12 (44.4)26 (59.1)22 (56.4)16 (45.7)32 (55.2)17 (89.5)9 (24.3)170 (52.5)
Protocol CIT-07
 Donor characteristic
  Age (years)46 (9)50 (6)39 (19)37 (22)49 (27)43 (21)37 (7)53 (26)42 (19)
  Height (cm)172.0 (5.0)167.8 (11.6)182.9 (7.0)180.0 (12.4)175.0 (14.9)175.1 (13.5)174.4 (9.8)172.7 (15.3)177.8 (12.7)
  Weight (kg)85.0 (28.5)93.0 (28.1)113.4 (13.7)90.7 (28.0)113.0 (54.9)112.5 (16.6)113.6 (29.0)93.0 (32.0)107.0 (31.0)
  BMI (kg/m2)27.1 (7.7)31.9 (5.6)34.7 (4.6)28.2 (11.2)36.0 (14.8)36.3 (5.2)38.4 (12.9)28.6 (13.6)33.4 (8.2)
  Cold ischemic time (h)6.0 (5.4)8.5 (4.6)7.4 (2.5)6.7 (3.2)7.9 (2.7)8.9 (5.4)7.8 (0.7)7.8 (0.7)7.7 (3.4)
 Product manufacture
  Final trimmed pancreas weight (g)95 (37)93 (46)109 (28)103 (40)101 (63)102 (64)112 (31)124 (19)106 (40)
  Total packed tissue volume (mL)45 (6)45 (5)44 (14)45 (30)40 (46)39 (18)25 (1)40 (10)44 (16)
  Postdigestion IPN865,000 (720,723)718,000 (404,000)1,183,000 (585,500)542,000 (556,000)421,250 (30,500)351,000 (145,524)548,500 (231,000)853,125 (111,250)537,500 (528,000)
  Postdigestion IEQ732,250 (128,250)728,842 (314,642)1,074,360 (277,000)693,520 (615,069)613,534 (447,954)523,218 (359,927)787,250 (397,160)666,068 (93,080)708,470 (382,000)
  Postdigestion index1.10 (0.40)1.00 (0.20)0.95 (0.15)1.30 (0.10)1.30 (0.30)1.70 (1.40)1.55 (0.10)0.70 (0.00)1.20 (0.60)
  Postpurification IPN451,750 (188,000)362,000 (177,000)506,000 (243,500)368,250 (216,000)268,750 (188,750)233,475 (150,900)350,750 (205,000)630,000 (80,000)390,500 (287,750)
  Postpurification IEQ620,000 (258,506)641,275 (273,010)672,547 (226,290)556,181 (280,726)588,602 (338,136)503,459 (245,830)569,038 (438,968)492,736 (96,845)582,370 (267,931)
  Postpurification index1.40 (0.50)1.70 (0.90)1.30 (0.40)1.50 (0.50)1.90 (0.70)1.95 (0.85)1.75 (0.70)0.90 (0.30)1.50 (0.60)
  Postculture IPN396,000 (186,000)242,688 (115,188)265,250 (180,750)282,000 (145,750)197,000 (197,095)219,250 (103,500)210,500 (81,690)484,000 (223,510)276,000 (171,000)
  Postculture IEQ469,400 (120,380)579,915 (139,065)637,280 (243,020)455,098 (235,652)402,600 (168,601)422,665 (284,797)598,874 (168,600)370,034 (43,550)490,174 (226,835)
  Postculture (index)1.40 (0.50)1.55 (0.60)1.30 (0.90)1.30 (0.40)1.30 (0.40)1.85 (0.90)1.90 (0.40)0.80 (0.20)1.40 (0.70)
 Process recovery (IEQ/g trimmed pancreas)
  Postdigestion8,135 (2,300)6,531 (3,812)8,958 (2,876)6,270 (4,417)5,708 (2,919)4,720 (2,042)7,778 (3,064)6,422 (1,527)6,813 (3,672)
  Postpurification5,877 (4,544)5,715 (3,029)6,601 (1,883)5,884 (3,942)5,442 (1,594)4,634 (1,614)6,201 (3,501)4,371 (1,160)5,471 (2,709)
  Postculture4,925 (2,730)5,235 (1,845)5,749 (1,273)5,305 (2,614)4,525 (1,565)4,064 (662)5,662 (2,427)3,319 (1,154)4,730 (2,156)
 Process yield (%)
  Postpurification73 (24)84 (6)77 (19)81 (25)106 (42)92 (31)84 (11)79 (13)82 (22)
  Postculture81 (17)82 (17)91 (13)88 (11)80 (27)89 (20)96 (30)75 (8)86 (17)
  Overall61 (25)71 (13)68 (17)71 (20)73 (25)85 (39)79 (7)60 (12)71 (22)
 Final product release test results
  GSIR index (high-purity islets, preculture)2.1 (0.7)1.6 (1.7)3.5 (3.9)2.3 (1.2)2.9 (3.7)2.1 (2.0)2.6 (2.9)2.0 (0.2)2.1 (2.0)
  GSIR index (high-purity islets, postculture)2.6 (0.4)3.8 (2.7)2.2 (1.1)1.6 (1.1)2.9 (2.4)1.7 (1.8)2.2 (1.2)2.5 (0.7)2.3 (1.6)
  Settled tissue volume (mL)5.0 (1.5)3.9 (1.7)6.0 (4.2)3.0 (4.0)2.9 (2.6)2.5 (1.1)3.9 (3.4)2.2 (0.8)4.0 (3.8)
  Total transplant (IEQ)462,510 (119,531)573,116 (169,216)614,578 (190,868)467,135 (245,378)396,926 (166,745)406,982 (281,925)573,643 (178,843)366,390 (49,896)480,500 (231,139)
  Islet quantity dose/batch (IEQ/kg recipient BW)6,535 (1,390)8,387 (2,943)7,813 (2,416)6,561 (3,338)5,924 (2,267)6,359 (1,903)9,035 (1,518)5,277 (1,892)6,694 (2,800)
  Viability bag #197.00 (6.20)93.10 (7.50)89.80 (7.70)93.00 (1.00)96.24 (2.32)94.11 (3.48)100.00 (0.00)96.60 (4.90)93.80 (6.34)
  Endotoxins (EU/kg recipient BW)0.07 (0.05)0.58 (0.38)0.66 (0.72)0.12 (0.54)0.02 (0.06)1.14 (1.53)3.41 (1.89)0.88 (0.20)0.44 (0.86)
  Islet concentration total (IEQ/mL total settled tissue volume)78,512 (31,467)155,391 (141,985)89,580 (105,652)173,613 (101,180)134,813 (188,556)210,443 (178,965)146,832 (131,407)218,409 (110,943)134,813 (131,407)
  Gram stainAll negativeAll negativeAll negativeAll negativeAll negativeAll negativeAll negativeAll negativeAll negative
Sterility
 Negative7 (77.8)4 (100)16 (94.1)15 (100)7 (100)11 (91.7)4 (66.7)5 (100)69 (92)
 Positive2 (22.2)1 (5.9)1 (8.3)2 (33.3)6 (8)
PHPI calculated microscopic purity (%)70 (3)63 (20)66 (14)60 (15)57 (27)75 (32)70 (32)80 (13)69 (17)
  • Data are n (%) or median (IQR). EU, endotoxin units; IPN, islet particle number.

  • *The total number of lots includes Center 9, which did not manufacture PHPI for Protocol CIT-07.

  • †Postdigestion index: IPN values were available for 41 of 75 lots.

  • ‡GSIR preculture result was for information only and not used for lot release.