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),110,111 111
Ex€vivo cell based assay,35 35
Intramuscular injection (IM injection),3,131 131
Intravenous administration(IV administration),2,3,121,131 131
extractables and leachables from IV bags,121 121
clinical in-use studies,125,127 127
mAb aggregation,124,125 125
particulate formation,124,125 125
Ion exchange chromatography (IEX),18,20 20
Ionic strength,108,110 110
Irreversible aggregates,71 71
Isoelectric focusing (IEF),22,23 23
Isopropyl alcohol (IPA),17,18 18
Kinematic viscosity G′ measurements,177 177
for Newtonian fluid,165 165
impact from prefilled syringe components,157 157
clinical in-use studies,125,127 127
mAb aggregation,124,125 125
particulate formation,124,125 125
Light chains (LC),12,13 13
Light scattering,31,32 32
Liquid formulation development,106,107 107
Lyophilization formulation development,112,114 114
aggregate generation,115 115
unfolded and folded protein,113 113