Comparative removal of solvent and detergent viral inactivating agents from human intravenous immunoglobulin G preparations using SDR HyperD and C18 sorbents.
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 1g 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.
Burnouf
Thierry
T
Research Department, Human Protein Process Sciences (HPPS), 59800 Lille, France. tburnou@attglobal.net
Sayed
Makram A
MA
Radosevich
Miryana
M
El-Ekiaby
Magdy
M
D000180:Acrylic Resins / Q000737:chemistry*; D003902:Detergents / Q000737:chemistry* / Q000494:pharmacology; D006801:Humans; D007074:Immunoglobulin G; D017830:Octoxynol / Q000737:chemistry* / Q000494:pharmacology; D010755:Organophosphates / Q000737:chemistry* / Q000494:pharmacology; D012997:Solvents / Q000737:chemistry* / Q000494:pharmacology; D038301:Virus Inactivation / Q000187:drug effects
D000180:Acrylic Resins; D003902:Detergents; D007074:Immunoglobulin G; D010755:Organophosphates; D012997:Solvents; D017830:Octoxynol; C009524:tributyl phosphate