Visual Inspection Results from the Freeze-Thaw Experiments: Number of Vials Containing Lamellae Observed during the 1st and 2nd Inspections, and the Cumulative Counts. N/A - Not Applicable Because the 1st Inspection Was Not Performed
Study Arms | Antibody Drug Product Vials | Placebo Vials | |||||||
---|---|---|---|---|---|---|---|---|---|
A | B | C | D | E | F | G | H | ||
Brief Description | −30 °C → 5 °C, 2 cycles | −30°C → 5 °C, 2 cycles | −70 °C → 5 °C, 2 cycles | −70 °C → 5 °C, 2 cycles | −30 °C → 5 °C → −70 °C → 5 °C | −30 °C → −70 °C → 5 °C | −30 °C → 5 °C, 2 cycles | −70 °C → 5 °C, 2 cycles | |
Number of Lamellae Vials | 1st Inspection | 0 | N/A | 11 | N/A | N/A | N/A | 0 | N/A |
2nd Inspection | 0 | 0 | 2 | 30 | 17 | 5 | 0 | 3 | |
Cumulative | 0 | 0 | 13 | 30 | 17 | 5 | 0 | 3 |