Table 1 Characteristics and the results of the runs performed
From: Validation of the media fill method for Cytokine-Induced killer cells manufacturing process
Protocol | ID | Date | Production QO | L | TSB total volume (ml) | Sterility (N° of Units) | Fertility (N° of Units) | WC | OOS/ DEV | Compliance | |
|---|---|---|---|---|---|---|---|---|---|---|---|
2019 | |||||||||||
MF1 | MAN | 19095 | 08/07/2019 | QO1/ QO2 | L3 | 12,000 | 10 d0 tubes, 10 d4 tubes, 6 bags | 5 bags | YES | 1 | YES |
MF2 | MAN/ VAL | 19094 | 08/07/2019 | QO1/ QO3 | L3 | 12,000 | 10 d0 tubes, 10 d4 tubes, 6 bags | 5 bags | YES | 3 | YES |
MF3 | VAL | 19100 | 05/08/2019 | QO3 | L2 | 6,000 | 4 d0 tubes, 4 d4 tubes, 6 bags | 5 bags | NO | YES | |
MF4 | VAL | 19101 | 06/08/2019 | QO3 | L2 | 6,000 | 4 d0 tubes, 4 d4 tubes, 6 bags | 5 bags | 1 | YES | |
2020 | |||||||||||
MF5 | MAN/ VAL | 20127 | 21/07/2020 | QO1/ QO5 | L2 | 11,000 | 10 d0 tubes, 10 d4 tubes, 6 bags | 5 bags | YES | 4 | YES |
MF6 | MAN | 20133 | 27/07/2020 | QO4/ QO3 | L2 | 11,520 | 10 d0 tubes, 10 d4 tubes, 6 bags | 5 bags | YES | 4 | YES |
MF7 | VAL | 20156 | 08/09/2020 | QO5 | L3 | 6,000 | 4 d0 tubes, 4 d4 tubes, 6 bags | 5 bags | NO | YES | |
MF8 | VAL | 20176 | 12/10/2020 | QO5 | L3 | 6,000 | 10 d0 tubes, 10 d4 tubes, 6 bags | 5 bags | NO | YES | |
2021 | |||||||||||
MF9 | MAN | 21115 | 21/06/2021 | QO4/QO5 | L3 | 12,000 | 1* d0 tubes, 1*d4 tubes, 12 bags | 12 bags | YES | NO | YES |
MF10 | MAN | 21133 | 26/07/2021 | QO3/QO4 | L4 | 12,000 | 1* d0 tubes, 1* d4 tubes, 12 bags | 12 bags | YES | NO | YES |
MF11 | MAN | 21143 | 24/08/2021 | QO5/QO3 | L4 | 12,000 | 1* d0 tube, 1* d4 tube, 12 bags | 12 bags | YES | 6 | YES |
2022 | |||||||||||
MF12 | MAN | 22099 | 05/07/2022 | QO4/QO3 | L4 | 12,000 | 1* d0 tubes, 1* d4 tubes, 12 bags | 12 bags | YES | NO | YES |
MF13 | MAN | 22106 | 26/07/2022 | QO5/QO4 | L3 | 12,000 | 1* d0 tubes, 1* d4 tubes, 12 bags | 12 bags | YES | NO | YES |
MF14 | VAL | 22146 | 27/09/2022 | QO6 | L3 | 6400 | 1* d0 tubes, 1* d4 tubes, 6 bags | 6 bags | NO | YES | |
MF15 | VAL | 22174 | 07/11/2022 | QO6 | L3 | 6,400 | 1* d0 tubes, 1* d4 tubes, 6 bags | 6 bags | NO | YES | |
MF16 | VAL | 22179 | 14/11/2022 | QO4/QO5/ QO6* | L3 | 12,000 | 1* d0 tubes, 1* d4 tubes, 12 bags | 12 bags | YES | NO | YES |