The process: New methods of purification and viral safety

Pharmacotherapy

Volumn 25, Issue 11 II, 2005, Pages

  Schleis, Thomas G ^a,b  

^a PLLC   (United States)

^b NONE   (United States)

Author keywords

Prions; Process; Product safety; Purification; Viral safety

Indexed keywords

CARIMUNE NF; GAMMAGARD S/D; GAMMAR P; HUMAN IMMUNOGLOBULIN; IMMUNOGLOBULIN; IMMUNOGLOBULIN G; UNCLASSIFIED DRUG;

CONFERENCE PAPER; DRUG EFFICACY; DRUG MANUFACTURE; DRUG PURIFICATION; DRUG SAFETY; DRUG TOLERABILITY; HEPATITIS C VIRUS; HUMAN; PRION DISEASE; VIRAL CONTAMINATION; VIRUS TRANSMISSION;

DRUG CONTAMINATION; DRUG INDUSTRY; DRUG TOXICITY; HUMANS; IMMUNOGLOBULINS, INTRAVENOUS; IMMUNOLOGIC FACTORS; PRION DISEASES; VIRUS DISEASES; VIRUS INACTIVATION;

EID: 27644562752     PISSN: 02770008     EISSN: None     Source Type: Journal    
DOI: 10.1592/phco.2005.25.11part2.73S     Document Type: Conference Paper

References (16)

1. Winters RE, Gitnick GL. Australia antigen related hepatitis transmitted by gamma-globulin [letter]. Gastroenterology 1971;60:732.
2. Nakamura S, Sato T. Acute hepatitis B after administration of gammaglobulin [letter]. Lancet 1976;i:487.
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.
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.
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.
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.
7. Swenson MR. Autoimmunity and immunotherapy. J Intraven Nurs 2000;23(suppl 5):S8-13.
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.
9. Siegel J. Viral safety issues in IGIV products. Pharm Ther 1996;April(suppl 1):21S-4.
10. Collinge J, Palmer MS, eds. Human prion diseases. In: Prion diseases. Oxford, England: Oxford University Press, 1997.
11. Darnell RB. Memory, synaptic translation, and...prions? Cell 2003;115:767-70.
12. Knight R, Stewart G. The new variant form of Creutzfeldt-Jakob disease. FEMS Immunol Med Microbiol 1998;21:97-100.
13. Llewelyn CA, Hewitt PE, Knight RS, et al. Possible transmission of variant Creutzfeldt-Jakob disease by blood transfusion. Lancet 2004;363:417-21.
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.