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Artificial Cells, Blood Substitutes, and Biotechnology Volume 26, 1998 - Issue 5-6
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Original Article

Validation of the Heat Treatment Step Used in the Production of Diaspirln Crosslinked Hemoglobin (DCLHb™) For Viral Inactivation

M. Azari Blood Substitutes Program, Baxter Healthcare Corporation, Round Lake, Illinois, 60073, USA
,
A. Ebeling Blood Substitutes Program, Baxter Healthcare Corporation, Round Lake, Illinois, 60073, USA
,
R Baker Blood Substitutes Program, Baxter Healthcare Corporation, Round Lake, Illinois, 60073, USA
,
K. Burhop Blood Substitutes Program, Baxter Healthcare Corporation, Round Lake, Illinois, 60073, USA
,
T. Camacho Blood Substitutes Program, Baxter Healthcare Corporation, Round Lake, Illinois, 60073, USA
,
T. Estep Blood Substitutes Program, Baxter Healthcare Corporation, Round Lake, Illinois, 60073, USA
,
S. Guzder Blood Substitutes Program, Baxter Healthcare Corporation, Round Lake, Illinois, 60073, USA
,
T. Marshall Blood Substitutes Program, Baxter Healthcare Corporation, Round Lake, Illinois, 60073, USA
,
K. Rohn Blood Substitutes Program, Baxter Healthcare Corporation, Round Lake, Illinois, 60073, USA
,
R Sarajari Blood Substitutes Program, Baxter Healthcare Corporation, Round Lake, Illinois, 60073, USA
,
J. A. Boose Process Validation Division, Microbiological Associates, Inc., Rockville, Maryland, 20850, USA
,
G. Gauvin Process Validation Division, Microbiological Associates, Inc., Rockville, Maryland, 20850, USA
,
R Homer Process Validation Division, Microbiological Associates, Inc., Rockville, Maryland, 20850, USA
,
B. Lu Process Validation Division, Microbiological Associates, Inc., Rockville, Maryland, 20850, USA
,
L. Pearson Process Validation Division, Microbiological Associates, Inc., Rockville, Maryland, 20850, USA
&
D. Vacante Process Validation Division, Microbiological Associates, Inc., Rockville, Maryland, 20850, USA
 show all
Pages 577-582 | Published online: 04 Aug 2009

References

  • Azari M., Rohn K., Picken P. Diaspirin Crosslinked Hemoglobin (DCLHb): characterization of the process and the product manufactured under GMP requirements for clinical studies 1994. Art Cell, Blood Subs., Immob. Biotech., 22(3)701–708
  • Farmer M., Ebeling A., Marshall T., Hauck W., White E., Sun C. S., Long Z. Virus inactivation in diaspirin crosslinked hemoglobin solution by heat treatment. Biomat Artif Cells Immobil Biotech 1991; 12(2)380
  • Farmer M, Ebeling A., Marshall T., Hauck W., Sun C. S., White E., Long Z. Virus inactivation in diaspirin crosslinked hemoglobin solution by heat treatment. Transfusion 1992; 32S: 8S
  • Fanner M., Ebeling A., Marshall T., Hauck W., Sun C. S., White E., Long Z. Validation of virus inactivation by heat treatment in the manufacture of diaspirin crosslinked hemoglobin. Biomat Artif Cells Immobil Biotech 1992; 20: 429–433; 2–4

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