SPADA Book - April 11, 2017
Homogeneity Study
Viability = 2.50 ± 0.58 %
Technique
Cells per vial* x 10 7 3.81 ± 0.51 (13.3 %) 0.095 ± 0.018 (18.9 %)
Vials
Reps
Coulter – Total cells
28 14
2 1
Plating – CFUs
*± 95 % expanded uncertainty (coefficient of variation)
Time 1 Time 2 (~15 d between Times 1 and 2)
6.0E+07
4.5E+07
3.0E+07
1.5E+07
Number of cells per vial
0.0E+00
1
2
0
5
10
15
20
25
30
Timepoint
15
Long-term Stability Study
To establish shelf-life
Real-time stability (~ 2 years)
4 °C
Time (d)
0 178 365 472 788
2.E+07 3.E+07 4.E+07 5.E+07 6.E+07
Stability Data
Upper Control Limit Average (from Homogeneity) Lower Control Limit
Total cells per vial
0
0
0
0
145
145
145
145
145
178 Time (d) 178 178
178
178
365
381
416
472
758
788
788
Mean ± 3 ı UCL: upper control level LCL: lower control level
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