Biomedical Engineering Reference
In-Depth Information
Figure
4.7.
Protease digestion of monoclonal antibodies to produce Fab or F(ab
0
)2.
TABL E 4.1.
In Vitro Characterization of Motavizumab Variants
F Protein Binding
ELISA
(% of Reference Standard)
RSV Neutralization
Activity
(ED
50
Ratio)
SPR Binding
(K
d
)toF
Protein (pM)
Sample
Description
Control sample
98
1.0
4.0
Deglycosylated
102
1.0
6.2
G0 enriched
95
1.0
5.9
G2 enriched
112
0.9
5.0
IgG control
NA
No
NA
Binds to F protein
a
Ye s
a
Fab
13.0
F(ab
0
)
2
Binds to F protein
a
Ye s
a
3.4
NA: not applicable.
a
Because of expected differences in avidity for Fab and F(ab
0
)
2
samples, it is not possible to directly compare
them to reference standard at the same concentration.
TABL E 4.2.
In Vitro Characterization of Palivizumab Variants
Sample
Description
F Protein Binding ELISA
(% of Reference Standard)
RSV
Neutralization
SPR Binding
(K
d
) to F Protein (nM)
Control sample
98
Yes
0.81
Deglycosylated
98
Yes
0.88
G0 enriched
92
Yes
0.87
G2 enriched
98
Yes
1.04
Binds to F protein
a
Fab
Yes
12.7
Binds to F protein
a
F(ab
0
)2
Yes 0.61
a
Because of expected differences in avidity for Fab and F(ab
0
)
2
samples, it is not possible to directly compare
them to the reference standard at the same concentration.
