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)
Parathyroid hormone (PTH),111,112 112
Particulates evaluation methods,34 34
PEG. See Polyethylene glycol pH control buffers for,107 107
Pharmaceutical development,1 1
contributors to successful,2 2
Physical degradation,67 67
Chemical degradation aggregation,70,73 73
of mAb during long-term storage,73,75 75
of mAb during unit processing operations,75,77 77
conformational changes,68,70 70
Polyacrylamide gel electrophoresis(PAGE),21,22 22
Polyethylene glycol (PEG),112,114 114
Polyolefin (PO),121,122 122
Polysorbate 20 (PS20),54,56,125 125
Polyvinyl chloride (PVC),121,122 122
development for mAb,36 36
active concentration of 4D5 HER2 murine mAb,37 37
ELISA-based receptor inhibition assay,38 38
ex€vivo cell based,35 35
in€vitro analytical based,36 36
in€vivo animal based,35 35
Prefilled syringe,153,154 154
filling of highly concentrated mAbs into,160 160
leachables impact,157 157
problems with tungsten,159 159