The process: New methods of purification and viral safety.
From the transmission of hepatitis C virus by gammaglobulins in 1994 to the emergence of new viruses and concern over prions, intravenous immunoglobulin (IGIV) manufacturers have continued to address safety issues and respond to changing needs. New IGIV products not only provide superior antiviral safety, but also show advances in product purity and manufacturing processes. Several manufacturers have also addressed the concern over prion transmission. The sum of the processes used have collectively ensured continuous product safety. Newer products will be further differentiated by their tolerability and efficacy profiles.
Schleis
Thomas G
TG
Northwest Medical Specialties, PLLC, Tacoma, Washington, USA. t.schleis@wavecable.com
D004340:Drug Contamination / Q000517:prevention & control*; D004345:Drug Industry; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D016756:Immunoglobulins, Intravenous; D007155:Immunologic Factors; D017096:Prion Diseases / Q000635:transmission; D014777:Virus Diseases / Q000635:transmission*; D038301:Virus Inactivation
D016756:Immunoglobulins, Intravenous; D007155:Immunologic Factors