Table 2.
Summary of SBVPF Clinical Gammaretroviral Vector Products
| |
|
|
|
Titer (TU/ml, × 105)a |
|
|
|
|---|---|---|---|---|---|---|---|
| Clinical vector | Target antigen | No. of harvests | Production volume (L) | Pre-filtration | Post-filtration | Recovery (%) | Colonies detectedb |
| mF5TCR | MART-1 | 5 | 15 | 5.6 ± 0.6c | 4.3 ± 1.0c | 76.8 | 0/5 |
| F5TCR | MART-1 | 6 | 18 | 7.4 ± 0.2d | 7.3 ± 0.1d | 98.6 | 0/6 |
| CD 19 CAR | CD 19 | 6 | 18 | 5.2 ± 0.6d | 4.7 ± 0.3d | 90.4 | 0/6 |
| CEA TCR | CEA | 6 | 18 | 8.0 ± 0.1d | 7.9 ± 0.1d | 98.8 | 0/6 |
| 2G1 TCR | Renal cell carcinoma | 6 | 18 | 6.0 ± 0.4d | 5.8 ± 0.4d | 96.7 | 0/6 |
a
Transducing units (TU)/ml = (% tetramer+)(total cells) (dilution factor)/supernatant volume. TCR or CAR expression was determined as described in Materials and Methods.
b
A 100-ml bag from each harvest was thawed and tested for residual viable packaging cells using the centrifugation RCDA as described in Materials and Methods.
c
Average titer of all harvests for a given product ± SEM for two separate patient PBLs.
d
Average titer of all harvests for a given product ± SEM for three separate patient PBLs.