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