Table 1.
Experimental set up of all drug samples tested.
| Container | Dilution | Temp | BL | 30 d | 60 d | 90 d | 120 d | 180 d | TOTAL SAMPLES |
|---|---|---|---|---|---|---|---|---|---|
| CT | 1/50 (1 mg/mL) | RT | 3# | 3 | 3 | 3 | N/A | 3# | 15 |
| RF | N/A | 3 | 3 | 3 | N/A | 3# | 12 | ||
| FZ | N/A | 3 | 3 | 3 | N/A | 3# | 12 | ||
| SV | 1/50 (1 mg/mL) | RT | N/A | 3 | 3 | 3 | N/A | 3# | 12 |
| RF | N/A | 3 | 3 | 3 | N/A | 3# | 12 | ||
| FZ | N/A | 3 | 3 | 3 | N/A | 3# | 12 | ||
| SV | Stock (50 mg/mL) | RF | 3# | 3 | 3 | 3 | N/A | 3# | 15 |
| FT | N/A | N/A | 3 | 3+ 3*# | 3*# | N/A | 12 | ||
| CT = conical tube, SV = sterile vial, BL = baseline. RT = room temperature. RF = refrigerated. FZ = frozen, FT = freeze-thaw, N/A = not applicable. Numbers indicate number of 7 mL samples during each time point. * = sample was taken out of freezer 30 d prior. # = in addition to sterility and potency, the sample was also tested for endotoxin. | |||||||||