Abstract
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.
Keywords: process, purification, viral safety, product safety, prions
References
- 1. Winters RE, Gitnick GL. Australia antigen related hepatitis transmitted by gamma‐globulin [letter]. Gastroenterology 1971;60: 732. [Google Scholar]
- 2. Nakamura S., Sato T.. Acute hepatitis B after administration of gammaglobulin [letter]. Lancet 1976;i: 487. [DOI] [PubMed] [Google Scholar]
- 3. Centers for Disease Control and Prevention . Outbreak of hepatitis C associated with intravenous immunoglobulin administration—United States, October 1993–June 1994. MMWR Morb Mortal Wkly Rep 1994;43(28): 505–9. [PubMed] [Google Scholar]
- 4. Miller JL, Petteway SR Jr, Lee DC. Ensuring the pathogen safety of intravenous immunoglobulin and other human plasma‐derived therapeutic proteins. J Allergy Clin Immunol 2001;108(suppl 4): S91–4. [DOI] [PubMed] [Google Scholar]
- 5. Lee D., Remington KM, Petteway SR Jr. Production of intravenous immunoglobulin and other plasma‐derived products: focus on pathogen safety. J Intraven Nurs 2000;23(suppl 5): S18–22. [Google Scholar]
- 6. Wick M., Wick M., Heberger S., Simon H., Fateh‐Moghadam A.. Quality control of IgG preparations by protein analysis. Infusions Ther Transfusions Med 1996;23(suppl 4): 55–9. [Google Scholar]
- 7. Swenson MR. Autoimmunity and immunotherapy. J Intraven Nurs 2000;23(suppl 5): S8–13. [Google Scholar]
- 8. McCue JP, Hein RH, Tenold R.. Three generations of immunoglobulin G preparations for clinical use. Rev Infect Dis 1986;8(suppl 4): S374–81. [DOI] [PubMed] [Google Scholar]
- 9. Siegel J.. Viral safety issues in IGIV products. Pharm Ther 1996;April(suppl 1): 21S–4. [Google Scholar]
- 10. Collinge J., Palmer MS, eds. Human prion diseases In: Prion diseases. Oxford, England: Oxford University Press, 1997. [Google Scholar]
- 11. Darnell RB. Memory, synaptic translation, and…prions Cell 2003;115: 767–70. [DOI] [PubMed] [Google Scholar]
- 12. Knight R., Stewart G.. The new variant form of Creutzfeldt‐Jakob disease. FEMS Immunol Med Microbiol 1998;21: 97–100. [DOI] [PubMed] [Google Scholar]
- 13. Llewelyn CA, Hewitt PE, Knight RS, et al Possible transmission of variant Creutzfeldt‐Jakob disease by blood transfusion. Lancet 2004;363: 417–21. [DOI] [PubMed] [Google Scholar]
- 14. ZLB Behring . Carimune NF package insert. Berne, Switzerland; 2005.
- 15. Talecris Biotherapeutics . Gamunex package insert. Clayton, NC; 2005.
- 16. Octapharma USA . Data on file. Centreville, VA; 2004.