Virus inactivation/elimination in therapeutic protein concentrates.
Concern for virus transmission from intravenous biological products, derived from natural and biotechnological sources, has prompted us to investigate various methods for virus inactivation while preserving the biological activity of the therapeutic entity. This concern is currently acute regarding the presence of HIV in purified human plasma protein concentrates. Four different methods of virus removal (1) heating in solution; (2) use of lipid solvents; (3) low pH treatment, and (4) partitioning during purification, are reported for various plasma proteins that have been spiked with model viruses. General virus inactivation strategies for therapeutic protein concentrates are discussed.
Mitra
G
G
Biological Research and Development, Cutter Biological, Miles Inc., Berkeley, Calif.
Dobkin
M B
MB
Wong
M F
MF
Mozen
M M
MM
D000818:Animals; D001688:Biological Products / Q000302:isolation & purification; D001769:Blood / Q000382:microbiology*; D001798:Blood Proteins / Q000302:isolation & purification; D004340:Drug Contamination; D006358:Hot Temperature; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008055:Lipids / Q000494:pharmacology; D008722:Methods; D012190:Retroviridae / Q000187:drug effects / Q000502:physiology; D012997:Solvents / Q000494:pharmacology; D018406:Virus Physiological Phenomena; D014780:Viruses / Q000187:drug effects
D001688:Biological Products; D001798:Blood Proteins; D008055:Lipids; D012997:Solvents