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单克隆抗体应对最终药物的生产,配制,递送和稳定性方面的挑战 407条(本栏目收费,不能显示细节,电话13136136841)
Ethylenediaminetetraacetic acid (EDTA),110,111
110 111
Ex€vivo cell based assay,35
35
Intramuscular injection (IM injection),3,131
3 131
Intravenous administration(IV administration),2,3,121,131
2 3 121 131
extractables and leachables from IV bags,121
121
clinical in-use studies,125,127
125 127
mAb aggregation,124,125
124 125
particulate formation,124,125
124 125
Ion exchange chromatography (IEX),18,20
18 20
Ionic strength,108,110
108 110
Irreversible aggregates,71
71
Isoelectric focusing (IEF),22,23
22 23
Isomerization,50,51
50 51
Isopropyl alcohol (IPA),17,18
17 18
Kinematic viscosity G′ measurements,177
177
for Newtonian fluid,165
165
impact from prefilled syringe components,157
157
clinical in-use studies,125,127
125 127
mAb aggregation,124,125
124 125
particulate formation,124,125
124 125
Light chains (LC),12,13
12 13
Light scattering,31,32
31 32
Liquid formulation development,106,107
106 107
Lyophilization formulation development,112,114
112 114
aggregate generation,115
115
unfolded and folded protein,113
113