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15274084725)
Heavy chains (HC),12,13 13
Hemoglobin S (HbS),178,181 181
High viscosity,132,134 134
High-concentration mAb formulation analytical tools for,136 136
bioavailability of,135,136 136
High-concentration SC formulations alternative processes/formulations development,139,140 140
analytical tools for development,136 136
using existing manufacturing technologies,139,140 140
using formulation excipients to reduce viscosity,146,150 150
lyophilization of mAb,145 145
manufacturing impact,134,135 135
stability and final tonicity,143 143
High-performance liquid chromatography(HPLC),17 17
Higher order structure,68,69 69
Histidine oxidation,53,54 54
Horseradish peroxidase (HRP),36,37 37
HRP. See Horseradish peroxidase human growth hormone (hGH),35 35
Human hyaluronidase (rhuPH-20),148,150 150
Hydrophobic bond,20,21 21
Hydrophobic interaction chromatography(HIC),20,103 103
In silico methods to assessing protein degradation routes,105 105
In€vitro analytical based assay,36 36
In€vivo animal based assay,35 35
Inductively coupled plasma mass spectrometry (ICP-MS),157,159 159
Infrared spectroscopy (IR spectroscopy),28,29 29
Fc fusion and Fab conjugates,4,11 11