Virus removal from factor IX by filtration: validation of the integrity test and effect of manufacturing process conditions. [electronic resource]
Producer: 20100811Description: 303-10 p. digitalISSN:- 1095-8320
- 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
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Publication Type: Journal Article; Validation Study
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