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The Process: New Methods of Purification and Viral Safety
Author(s) -
Schleis Thomas G.
Publication year - 2005
Publication title -
pharmacotherapy: the journal of human pharmacology and drug therapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.227
H-Index - 109
eISSN - 1875-9114
pISSN - 0277-0008
DOI - 10.1592/phco.2005.25.11part2.73s
Subject(s) - medicine , tolerability , safety profile , manufacturing process , product (mathematics) , virology , risk analysis (engineering) , pharmacology , adverse effect , materials science , geometry , mathematics , composite material
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.