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Table 4 Effect of microfluidization processing on GLA-AF recovery and physicochemical stability when buffered with 12.5 mM ammonium phosphate

From: Optimizing manufacturing and composition of a TLR4 nanosuspension: physicochemical stability and vaccine adjuvant activity

Processing pressure (psi)

# Passes

Particle size (Z-ave, nm)

Pdl

Measured GLA concentration [100 ± 20 μg/ml target]

DM

T = 6 mo

DM

T = 6 mo

DM

T = 6 mo

20, 000

2

99 ± 3

108 ± 2

0.21 ± 0.01

0.32 ± 0.01

89 ± 1

96 ± 5

5

99 ± 4

-

0.25 ± 0.02

-

-

-

10

96 ± 1

124 ± 5

0.26 ± 0.01

0.53 ± 0.02

113 ± 4

94 ± 2

30, 000

2

99 ± 3

93 ± 1

0.21 ± 0.01

0.37 ± 0.02

89 ± 2

96 ± 5

5

67 ± 1

-

0.22 ± 0.01

-

-

-

 

10

68 ± 1

84 ± 2

0.27 ± 0.02

0.37 ± 0.02

105 ± 1

88 ± 3