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)
oxidation mechanism,51,62 62
physical degradation,67,77 77
Stability-indicating assays development,103,105 105
Stainless steel needles,157,159 159
Standard capillary electrophoresis instrumentation,167 167
Static light scattering (SLS),136,172,174 174
Sterile water for injection (SWFI),178,181 181
Storage modulus (G′),169 169
Subcutaneous (SC),2,3,71 71
analytical tools for high-concentration formulation development,136 136
bioavailability of high-concentration mAb formulation,135,136 136
challenge of formulating,131,132 132
impact on delivery due to high viscosity,132,134 134
manufacturing impact of high-concentration SC formulations,134,135 135
infusion devices,153,155 155
Sugars as lyoprotectants,115,117 117
Surface plasmon resonance (SPR),29 29
Surface-active agents,110,111 111
Tangential flow filtration (TFF),134,135,139,140 140
Target product profile (TPP),1 1
Tert-Butylhydroperoxide (TBHP),54,56 56
Tertiary structure,68,69 69
Tissue plasminogen activator (tPA),20 20
Glass capillary viscometry,165,166 166
Hagen Poiseuille equation,132,167,168 168
Halozyme technology,148,150 150