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