Table 3

Final COA

TestMethodRequirement
Identity
 Recipient identityVisual inspectionRecipient study ID and recipient medical record number on this COA and on each infusion bag label identical to that in the production batch record, section 12.3
 Islet identityDTZ stain and microscopic examinationIslets present in each product bag
Volumes in bags
 Suspension volumeDirect measurement200 mL per product bag ≤600 mL total in three product bags
 Settled tissue volumeDirect measurement after 5-min settling≤7.5 mL per product bag ≤15.0 mL total in three product bags
Potency
 GSIR (high-purity islets, preculture sample)ELISAFor information only, report stimulation index
 GSIR (high-purity islets, postculture sample)ELISAStimulation index >1
 Islet quantityDTZ stain and microscopic examinationFirst infusion: ≥5.0 × 103 IEQ/kg recipient BW (total IEQ/ infusion) Subsequent infusions: ≥4.0 × 103 IEQ/kg recipient BW (total IEQ/infusion)
 ViabilityFDA/PI stain and microscopic examination≥70% in each product bag
Purity
 Islet concentrationDTZ stain and microscopic examination≥20,000 total IEQ/mL total settled tissue volume
Safety
 AppearanceVisual inspectionLight yellow to amber liquid with visible aggregates in each product bag
 EndotoxinsLAL≤5.0 EU/kg of recipient BW (total EU/infusion)
 Sterility21 CFR 610.12No growth in each product bag
  • CFR, Code of Federal Regulations; EU, endotoxin unit; LAL, limulus amoebocyte lysate.