Optimal placement of a robust solvent/detergent process post viral ultrafiltration of an immune gamma globulin
AssigneeOrtho-Clinical Diagnostics, Inc.
InventorsRobert W. Van Holten, Stephen M. Autenrieth
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Abstract
The solvent-detergent (S/D) process is used to inactivate enveloped viruses in plasma products. While concentrations of 1.0% detergent and 0.3% tri-n-butyl phosphate solvent have been considered necessary for robust removal of viral activity, we show the effectiveness of solvent-detergent treatment after fractionation and nanofiltration of an immune gamma globulin preparation, which required significantly reduced concentrations of solvent and detergent. Reduced levels of solvent and detergent lead to greater efficiencies in their removal post-inactivation with the potential for greater yields and decreased processing costs.
Claims9
A method of virus inactivation in a post-manufacture immunoglobulin solution comprising:
- reducing the potential virus load of the immunoglobulin solution,
- adjusting the protein concentration of the immunoglobulin solution to equal or less than 6.0% w/v,
- adjusting the pH of the immunoglobulin solution to 6.3-6.4,
- contacting the immunoglobulin solution with 0.03% to 0.06% w/v of a di- or tri-alkyl phosphate solvent and 0.1% to less than 0.2% w/v of a non-ionic detergent for about 1 minute to about 1 hour at a temperature of 15-25° C.
Dependencies are inferred from the claim text.