Virus removal from factor IX by filtration: validation of the integrity test and effect of manufacturing process conditions.

Roberts, Peter L

Virus removal from factor IX by filtration: validation of the integrity test and effect of manufacturing process conditions. [electronic resource] - Biologicals : journal of the International Association of Biological Standardization Mar 2010 - 303-10 p. digital

Publication Type: Journal Article; Validation Study

1095-8320

10.1016/j.biologicals.2009.12.006 doi


Animals
Cattle
Cells, Cultured
Chlorocebus aethiops
Cricetinae
Decontamination--methods
Drug Contamination--prevention & control
Drug Industry--methods
Factor IX--chemistry
Filtration--methods
Humans
Manufactured Materials--standards
Microbiological Techniques--standards
Particle Size
Poliovirus--isolation & purification
Predictive Value of Tests
Sensitivity and Specificity
Vero Cells
Viruses--isolation & purification