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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)
Microflow digital imaging (MDI),34 34 
Microfluidic rheometry,167 167 
Modified Mooney equation,171 171 
Modulated DSC,32,33 32 33 
monoclonal antibodies (mAbs),2,3,12,14,17,45,93,131,193 2 3 12 14 17 45 93 131 193 
ADCs,193,194 193 194 
aggregation and viscosity,178,181 178 181 
analytical methods for evaluation biophysical methods,29,34 29 34 
chromatographic methods,17,21 17 21 
electrophoretic methods,21,24 21 24 
methods to particulates evaluation,34 34 
potency assays,35,37 35 37 
spectroscopic methods,24,29 24 29 
buffers for pH control,107 107 
ionic strength,108,110 108 110 
surface-active agents,110,111 110 111 
surfactants,110,111 110 111 
tonicity modifiers,108,110 108 110 
particulates evaluation methods in formulations,34 34 
protein therapeutics mAbs as,3 3 
protein/mAb stability,121,127 121 127 
stabilizers,112 112 
caveats,115,117 115 117 
lyophilization formulation development,112,114 112 114 
Protein protein interactions (PPI),139 139 
net charge impact vs. localized surface charge distribution,178,179 178 179 
aggregation and viscosity of mAbs,178,181 178 181 
nondissociable soluble aggregates of mAb1,181 181 
viscosity dependence on,171,175 171 175 
Pure red cell aplasia (PRCA),157 157 
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