Table 1:
Gap analysis of general collection, shipment, PBMC isolation, and cryopreservation practices across CPCI sites.
| Site A | Site B | Site C | Site D | Gap Identified | |
|---|---|---|---|---|---|
| Blood Collection Tubes | |||||
| Plasma isolation | EDTA | Sodium heparin | Sodium heparin | Sodium heparin | X |
| Serum isolation | Red top | - | - | - | X |
| Shipment of Correlative Samples | |||||
| Blood/bone marrow temperature | Ambient | Ambient | Ambient | Ambient | |
| CSF temperature | 4°C | 4°C | 4°C | 4°C | |
| Shipment container | Temperature-controlled | Temperature-controlled | Temperature-controlled | Temperature-controlled | |
| Qualified courier | Local courier | Local courier | Local courier | Local courier | |
| Density Gradient Centrifugation | |||||
| Whole blood lysis step to remove RBCs | Yes | Yes | Yes | Yes | |
| Tube type | 50mL SepMate | 50mL SepMate | 50mL Conical | 50mL Leukosep | X |
| Speed (x g) | 830 | 1200 | 400 | 800 | X |
| Time (min) | 20 | 10 | 30 | 15 | X |
| PBMC Centrifugation | |||||
| Speed (x g) | 250 | 400 | 400 | 500 | X |
| Time (min) | 10 | 5 | 10 | 10 | X |
| Cryopreservation | |||||
| Cell freezing | Media + 10% DMSO | Media + 10% DMSO | Media + 10% DMSO | Media + 10% DMSO | |
| Avg cell number cryopreserved/vial | 5–10×106 | 5–10×106 | 5–10×106 | 5–10×106 | |