Current and future approaches to ensure the viral safety of biopharmaceuticals.
Brorson
K
K
Division of Monoclonal Antibodies, CDER/FDA, Bethesda, MD 20892, USA. kurt.brorson@fda.hhs.gov
Norling
L
L
Hamilton
E
E
Lute
S
S
Lee
K
K
Curtis
S
S
Xu
Y
Y
D000818:Animals; D001688:Biological Products / Q000302:isolation & purification* / Q000592:standards*; D001702:Biopharmaceutics / Q000592:standards; D005374:Filtration; D006801:Humans; D016133:Polymerase Chain Reaction; D012449:Safety; D014481:United States; D014780:Viruses / Q000235:genetics / Q000302:isolation & purification*
D001688:Biological Products