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Table 1 Final product packaging and stability testing

From: Production of a cellular product consisting of monocytes stimulated with Sylatron® (Peginterferon alfa-2b) and Actimmune® (Interferon gamma-1b) for human use

 

Volume (mL)

viable cell concentration

Viable total nucleated cells

% TB viability

% Viable monocytes

Donor 1: 0-h

250

3.30E+05

8.25E+07

97

81.2

2-h stability (RT)

250

3.20E+05

8.00E+07

99

NA

4-h stability (RT)

250

3.40E+05

8.50E+07

97

80.3

Donor 2: 0-h

250

3.25E+05

8.13E+07

100

76.9

2-h stability (RT)

250

3.40E+05

8.50E+07

98

NA

4-h stability (RT)

250

3.05E+05

7.63E+07

97

64.9

Donor 3: 0-h

250

4.68E+06

1.17E+09

98

66

2-h stability (RT)

250

4.89E+06

1.22E+09

96

NA

4-h stability (RT)

250

4.47E+06

1.12E+09

93

66.9

Donor 4: 0-h

250

4.08E+06

1.02E+09

94

74.2

2-h stability (RT)

250

3.53E+06

8.83E+08

96

NA

4-h stability (RT)

250

3.31E+06

8.28E+08

95

73.7