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