Comparative removal of solvent and detergent viral inactivating agents from human intravenous immunoglobulin G preparations using SDR HyperD and C18 sorbents

Thierry Burnouf, Makram A. Sayed, Miryana Radosevich, Magdy El-Ekiaby

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3 Citations (Scopus)

Abstract

The capacity of hydrophobic octadecyl (C18) and SDR HyperD materials to remove the combination of 1% (v/v) solvent (tri-n-butyl phosphate, TnBP) with 1% (v/v) nonionic detergents (Triton X-100 and Triton X-45) used for viral inactivation of plasma-derived polyvalent intravenous immunoglobulin G (IVIG) preparation has been evaluated. Efficient removal of TnBP (<10 ppm in IVIG preparation) was found at ratios of 0.5 g of C18/7 ml of IVIG and 0.22 g of dry SDR HyperD/7 ml of IVIG. Binding capacities of TnBP were greater than 140 mg/g of C18 and greater than 318 mg/g of dry SDR HyperD. Complete removal of Triton X-45 (<2 ppm) was obtained at ratios of 1 g of C18/7 ml of IVIG and 0.44 g of dry SDR HyperD/7 ml of IVIG or above, corresponding to binding capacities in excess of 70 mg/g of C18 and in excess of 159 mg/g of dry SDR HyperD. Residual Triton X-100 was less than 30 ppm at a ratio of 4 g/14 ml of immunoglobulin G (IgG) for the C18 sorbent. Triton X-100 was less than 10 ppm when using SDR HyperD at a ratio of 0.66 g/7 ml of IgG, corresponding to a binding capacity of approximately 106 mg of Triton X-100/g of dry SDR HyperD. Good recoveries of IVIG were achieved in the effluent from both sorbents.

Original languageEnglish
Pages (from-to)69-73
Number of pages5
JournalAnalytical Biochemistry
Volume389
Issue number1
DOIs
Publication statusPublished - Jun 1 2009
Externally publishedYes

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Keywords

  • C18
  • Immunoglobulin G
  • SDR HyperD
  • Solvent/Detergent

ASJC Scopus subject areas

  • Biochemistry
  • Biophysics
  • Molecular Biology
  • Cell Biology

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