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Artificial Cells, Blood Substitutes, and Biotechnology Volume 22, 1994 - Issue 3
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Original Article

Diaspirin Crosslinked Hemoglobin (DCLHbTM): Characterization of the Process and the Product Manufactured Under GMP Requirements for Clinical Studies

M. Azari Blood Substitutes Program, Baxter Healthcare Corporation, Round Lake, Illinois, 60073
,
K. Rohn Blood Substitutes Program, Baxter Healthcare Corporation, Round Lake, Illinois, 60073
&
J. Picken Blood Substitutes Program, Baxter Healthcare Corporation, Round Lake, Illinois, 60073
Pages 701-708 | Published online: 11 Jul 2009

References

  • Estep T., Bobka E., Ebeling A., Hai T., Nelson Pankau D., Srnak R. A. Novel aspects of diaspirin crosslinked hemoglobin synthesis and purification. Biomat. Artif. Cells Artif. Org. 1989; 17(5)636
  • Mattia-Goldberg C. M., Reppucci T., Przybelski R. New blood product: Diaspirin crosslinked hemoglobin as a blood substitute. Effect on immunohematology testing. Transfusion 1992; 32: 8S
  • Estep T., Gonder J., Bornstein I., Young S., Johnson R. Biological evaluation of diaspirin crosslinked hemoglobin solutions. Biomat. Artif. Cells Immobil. Biotech. 1991; 20(2–4)603
  • Farmer M., Ebeling A., Marshall T., Hauck W., Sun C-S., Long Z. Validation of virus inactivation by heat treatment in the manufacture of diaspirin crosslinked hemoglobin. Biomat. Artif. Cells Immobil. Biotech. 1992; 20(2–4)429
  • Azari M., Ebeling A., Sun C-S. New blood product: Diaspirin crosslinked hemoglobin as a blood substitute. Virus inactivation and removal. Transfusion 1992; 32: 8S
  • Nelson D., Azari M., Baron C., Bush S., Catarello J., Marshall T., Spicuzza J., Zieske P. Preparation and characterization of diaspirin crosslinked hemoglobin solutions for pre-clinical studies. Biomat. Artif. Cells Immobil.Biotech. 1991; 14(2)452
  • Nelson D., Azari M., Brown R., Burhop K., Bush S., Catarello J., Chuang H., Downing C., Estep T., Loewn A., McClure K., McDaniel A., Michalek E., Mozier N., Rohn K., Spicuzza J., Zieske P., Zimmerman G. Preparation and characterization of diaspirin crosslinked hemoglobin solutions for preclinical studies. Biomat. Artif. Cells Immobil. Biotech. 1992; 20(2–4)423
  • Levchuk J. Good manufacturing practices and clinical supplies. J. Paren. Sci. Tech. 1991; 45(3)152
  • Avallone H. Manufacture of clinical products. Pharm. Tech.Sept. 1990; 150
  • Food and Drug Administration, Guideline on the preparation of investigational new drug products. Human and Animal March, 1991

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