Preparation of commercial quantities of a hyperimmune human intravenous immunoglobulin preparation against an emerging infectious disease: The example of pandemic H1N1 influenza

Transfusion

Volumn 52, Issue 4, 2012, Pages 803-809

  Kreil, Thomas R ^a,b,c   McVey, John K ^a,b,c   Lei, Laura Shau Ping ^a,b,c   Camacho, Laureano ^a,b,c   Wodal, Walter ^a,b,c   Kerschbaum, Astrid ^a,b,c   Segura, Edy ^a,b,c   Vandamme, Etienne ^a,b,c   Gavit, Patrick ^a,b,c   Ehrlich, Hartmut J ^a,b,c   Barrett, P Noel ^a,b,c   Baker, Donald A ^a,b,c  

^a BAXTER BIOSCIENCE   (Austria)

^b BAXTER HEALTHCARE CORPORATION   (United States)

^c Global Quality   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HEMAGGLUTINATION INHIBITING ANTIBODY; HYPERIMMUNE GLOBULIN; INFLUENZA VACCINE; VIRUS ANTIBODY;

ANTIBODY TITER; ARTICLE; BLOOD DONOR; CLINICAL PROTOCOL; COMMERCIAL PHENOMENA; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG MANUFACTURE; HEMAGGLUTINATION; HUMAN; INFLUENZA A (H1N1); INFLUENZA VIRUS A H1N1; PANDEMIC INFLUENZA; SCALE UP;

COMMUNICABLE DISEASES, EMERGING; HUMANS; IMMUNOGLOBULINS, INTRAVENOUS; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA, HUMAN; PANDEMICS;

EID: 84859770442     PISSN: 00411132     EISSN: 15372995     Source Type: Journal    
DOI: 10.1111/j.1537-2995.2011.03347.x     Document Type: Article

References (33)

1. Keller MA, Stiehm ER,. Passive immunity in prevention and treatment of infectious diseases. Clin Microbiol Rev 2000; 13: 602-14.
2. Casadevall A,. Antibody-based therapies for emerging infectious diseases. Emerg Infect Dis 1996; 2: 200-8.
3. Luke TC, Casadevall A, Watowich SJ, Hoffman SL, Beigel JH, Burgess TH,. Hark back: passive immunotherapy for influenza and other serious infections. Crit Care Med 2010; 38 Suppl: e66-73.
4. Rinaldo CR Jr., Passive immunization against poliomyelitis: the Hammon gamma globulin field trials, 1951-1953. Am J Public Health 2005; 95: 790-9.
5. Ben-Nathan D, Gershoni-Yahalom O, Samina I, Khinich Y, Nur I, Laub O, Gottreich A, Simanov M, Porgador A, Rager-Zisman B, Orr N,. Using high titer West Nile intravenous immunoglobulin from selected Israeli donors for treatment of West Nile virus infection. BMC Infect Dis 2009; 9: 18.
6. Planitzer CB, Modrof J, Kreil TR,. West Nile virus neutralization by US plasma-derived immunoglobulin products. J Infect Dis 2007; 196: 435-40.
7. Medina RA, Manicassamy B, Stertz S, Seibert CW, Hai R, Belshe RB, Frey SE, Basler CF, Palese P, Garcia-Sastre A,. Pandemic 2009 H1N1 vaccine protects against 1918 Spanish influenza virus. Nat Commun 2010; 1: 28.
8. Meunier I, Pillet S, Simonsen JN, von Messling V,. Influenza pathogenesis: lessons learned from animal studies with H5N1, H1N1 Spanish, and pandemic H1N1 2009 influenza. Crit Care Med 2010; 38 Suppl: e21-e29.
9. Kistner O, Crowe BA, Wodal W, Kerschbaum A, Savidis-Dacho H, Sabarth N, Falkner FG, Mayerhofer I, Mundt W, Reiter M, Grillberger L, Tauer C, Graninger M, Sachslehner A, Schwendinger M, Brühl P, Kreil TR, Ehrlich HJ, Barrett PN,. A whole virus pandemic influenza H1N1 vaccine is highly immunogenic and protective in active immunization and passive protection mouse models. PLoS ONE 2010; 5: e9349.
10. Wong HK, Lee CK, Hung IF, Leung JN, Hong J, Yuen KY, Lin CK,. Practical limitations of convalescent plasma collection: a case scenario in pandemic preparation for influenza A (H1N1) infection. Transfusion 2010; 50: 1967-71.
11. Beigel JH, Voell J, Huang CY, Burbelo PD, Lane HC,. Safety and immunogenicity of multiple and higher doses of an inactivated influenza A/H5N1 vaccine. J Infect Dis 2009; 200: 501-9.
12. Teschner W, Butterweck HA, Auer W, Muchitsch EM, Weber A, Liu SL, Wah PS, Schwarz HP,. A new liquid, intravenous immunoglobulin product (IGIV 10%) highly purified by a state-of-the-art process. Vox Sang 2007; 92: 42-55.
13. Poelsler G, Berting A, Kindermann J, Spruth M, Hammerle T, Teschner W, Schwarz HP, Kreil TR,. A new liquid intravenous immunoglobulin with three dedicated virus reduction steps: virus and prion reduction capacity. Vox Sang 2008; 94: 184-92.
14. Wu JT, Lee CK, Cowling BJ, Yuen KY,. Logistical feasibility and potential benefits of a population-wide passive-immunotherapy program during an influenza pandemic. Proc Natl Acad Sci U S A 2010; 107: 3269-74.
15. Low DE, Mazzulli T, Marrie T,. Progressive and nonresolving pneumonia. Curr Opin Pulm Med 2005; 11: 247-52.
16. Centers for Disease Control and Prevention. Interim results: influenza A (H1N1) 2009 monovalent vaccination coverage-United States, October-December 2009. MMWR Morb Mortal Wkly Rep 2010; 59: 44-8.
17. Centers for Disease Control and Prevention. CDC estimates of 2009 H1N1 influenza cases, hospitalizations and deaths in the United States, April 2009-January 16, 2010. 2010. [cited 2011 Feb 11]. Available from: URL
18. Jeong EK, Sung HM, Kim IS,. Inactivation and removal of influenza A virus H1N1 during the manufacture of plasma derivatives. Biologicals 2010; 38: 652-7.
19. Kreil TR, Unger U, Orth SM, Petutschnig G, Kistner O, Poelsler G, Berting A,. H5N1 influenza virus and the safety of plasma products. Transfusion 2007; 47: 452-9.
20. Food and Drug Administration. Note for guidance on harmonisation of requirements for influenza vaccines-CPMP/BWP/214/96. CPMP/BWP/214/96 2008.
21. Food and Drug Administration. Guidance for industry clinical data needed to support the licensure of seasonal inactivated influenza vaccines FDA CBER May. 2007.
22. Greenberg ME, Lai MH, Hartel GF, Wichems CH, Gittleson C, Bennet J, Dawson G, Hu W, Leggio C, Washington D, Basser RL,. Response after one dose of a monovalent influenza A (H1N1) 2009 vaccine-preliminary report. N Engl J Med 2009; 361: 2405-13.
23. Plennevaux E, Sheldon E, Blatter M, Reeves-Hoche MK, Denis M,. Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials. Lancet 2010; 375: 41-8.
24. Arguedas A, Soley C, Lindert K,. Responses to 2009 H1N1 vaccine in children 3 to 17 years of age. N Engl J Med 2010; 362: 370-2.
25. Yunoki M, Kubota-Koketsu R, Urayama T, Sasaki T, Analiwa D, Konoshima Y, Ideno S, Fukunaga Y, Morikawa S, Hiroi S, Takahashi K, Okuno Y, Hagiwara K, Ikuta K,. Significant neutralizing activity of human immunoglobulin preparations against pandemic 2009 H1N1. Br J Haematol 2009; 148: 953-5.
26. Hong DK, Tremoulet AH, Burns JC, Lewis DB,. Cross-reactive neutralizing antibody against pandemic 2009 H1N1 influenza A virus in intravenous immunoglobulin preparations. Pediatr Infect Dis J 2011; 30: 67-9.
27. Plasma Protein Therapeutics Association. Quality standards of excellence, assurance and leadership (QSEAL). 2010. [cited 2011 Feb 11]. Available from: URL
28. Chen LF, Dailey NJ, Rao AK, Fleischauer AT, Greenwald I, Deyde VM, Moore ZS, Anderson DJ, Duffy J, Gubareva LV, Sexton DJ, Fry AM, Srinivasan A, Wolfe CR,. Cluster of oseltamivir-resistant 2009 pandemic influenza A (H1N1) virus infections on a hospital ward among immunocompromised patients-North Carolina, 2009. J Infect Dis 2011; 203: 838-46.
29. Lee EH, Wu C, Lee EU, Stoute A, Hanson H, Cook HA, Nivin B, Fine AD, Kerker BD, Harper SA, Layton MC, Balter S,. Fatalities associated with the 2009 H1N1 influenza A virus in New York city. Clin Infect Dis 2010; 50: 1498-504.
30. Louie JK, Acosta M, Jamieson DJ, Honein MA,. Severe 2009 H1N1 influenza in pregnant and postpartum women in California. N Engl J Med 2010; 362: 27-35.
31. Siston AM, Rasmussen SA, Honein MA, Fry AM, Seib K, Callaghan WM, Louie J, Doyle TJ, Crockett M, Lynfield R, Moore Z, Wiedeman C, Anand M, Tabony L, Nielsen CF, Waller K, Page S, Thompson JM, Avery C, Springs CB, Jones T, Williams JL, Newsome K, Finelli L, Jamieson DJ,; Pandemic H1N1 Influenza in Pregnancy Working Group. Pandemic 2009 influenza A (H1N1) virus illness among pregnant women in the United States. JAMA 2010; 303: 1517-25.
32. Spruth M, Kistner O, Savidis-Dacho H, Hitter E, Crowe B, Gerencer M, Bruhl P, Grillberger L, Reiter M, Tauer C, Mundt W, Barrett PN,. A double-inactivated whole virus candidate SARS coronavirus vaccine stimulates neutralising and protective antibody responses. Vaccine 2006; 24: 652-61.
33. Ehrlich HJ, Muller M, Oh HM, Tambyah PA, Joukhadar C, Montomoli E, Fisher D, Berezuk G, Fritsch S, Low-Baselli A, Vartian N, Bobrovsky R, Pavlova BG, Pöllabauer EM, Kistner O, Barrett PN,; Baxter H5N1 Pandemic Influenza Vaccine Clinical Study Team. A clinical trial of a whole-virus H5N1 vaccine derived from cell culture. N Engl J Med 2008; 358: 2573-84.