Strategies for viral removal and inactivation.
This paper provides an overview of the fundamentals of viral inactivation and clearance studies required for mammalian cell culture-derived biotechnological products. Strategies and considerations for evaluating the potential of purification processes to inactivate or remove adventitious or endogenous viruses are also discussed. The principles are illustrated by presenting data derived from the evaluation of clinical manufacturing processes for recombinant human interferon-beta and recombinant soluble CD4.
Burstyn
D G
DG
Alkermes, Inc., Cambridge, MA, USA.
Hageman
T C
TC
D000276:Adjuvants, Immunologic / Q000096:biosynthesis; D000998:Antiviral Agents; D001688:Biological Products; D015704:CD4 Antigens / Q000096:biosynthesis; D004340:Drug Contamination / Q000517:prevention & control*; D004345:Drug Industry / Q000592:standards; D005374:Filtration; D006801:Humans; D006863:Hydrogen-Ion Concentration; D000068556:Interferon beta-1a; D000068576:Interferon beta-1b; D016899:Interferon-beta / Q000096:biosynthesis; D011994:Recombinant Proteins / Q000096:biosynthesis; D014780:Viruses / Q000302:isolation & purification*
D000276:Adjuvants, Immunologic; D000998:Antiviral Agents; D001688:Biological Products; D015704:CD4 Antigens; D011994:Recombinant Proteins; C076613:recombinant soluble CD4; D000068576:Interferon beta-1b; D016899:Interferon-beta; D000068556:Interferon beta-1a