Table 1 Comparative description of SSCF and AP-HM methods. Comparative description of each critical steps of SVF manufacturing and associated quality controls performed at the SSCF and AP-HM cell-therapy facilities. DPBS Dulbecco’s phosphate-buffered saline, HSA human serum albumin, RL Ringer’s lactate
SSCF | AP-HM | ||
|---|---|---|---|
Adipose tissue harvesting | Manual or automatic harvesting using various canula | Manual harvesting using a Khouri Cannula after a strict aseptic skin preparation | |
Settling | 10 min | 5 min | |
Packaging in syringes | Directly packaging in 60-mL Luer Lock syringes. | Packaging in 60-mL Luer Lock syringes from a bag | |
Device preparation | Manual collection of AT | Tensioning the Celution® device, settlement of consumables, and seal check | |
Adipose tissue transfer | Into three 100-ml syringes | AT transfer in the Celution® device | |
Settling | 10 min | Automated | Visual check of discarding infiltration liquid |
Infiltration liquid removal | Yes | ||
Weighing | 150 ml of AT required | At least 100 mL of AT required | |
Washing | Twice with DPBS +/+ | From two to five washings with RL and visual check | |
Addition of the enzyme | Addition of Liberase® | Addition of Celase® in the device | |
Adipose tissue digestion | 45 min at 37 °C | Automated | 20 min at room temperature |
Washing | DPBS −/− + 1% HSA | Automated | With RL |
Filtration | 100 μm and 40 μm | NA | |
Collection of the SVF | SVF resuspended in 5% HSA | SVF resuspended in RL | |
Quality control sampling | 1) Cell count and viability 2) Evaluation of cell subset distribution with flow cytometry | 1) Cell count and viability 2) Evaluation of cell subset distribution with flow cytometry 3) CFU-F assay | |
Quality control of the end product | Microbiological control | Microbiological control | |
Environnemental control in process | 1) Passive agar (A class) (2x) 2) Contact agar bench (2x) 3) Gloves fingerprints after SVF packaging (2x) 4) Air impacting (A and B class) | 1) Passive agar (B class) 2) Passive agar (A class) 3) Gloves fingerprints after AT transfer 4) Gloves fingerprints after enzyme reconstitution and transfer 5) Gloves fingerprints after SVF collection 6) Contact agar bench 7) Contact agar working area 8) Gloves fingerprints after SVF packaging 9) Contact agar working area 10) Air impacting (A and B class) | |