Drug – bio-affecting and body treating compositions – Immunoglobulin – antiserum – antibody – or antibody fragment,... – Free from infectious agents
Reexamination Certificate
2005-11-15
2010-02-02
Saucier, Sandra E (Department: 1651)
Drug, bio-affecting and body treating compositions
Immunoglobulin, antiserum, antibody, or antibody fragment,...
Free from infectious agents
Reexamination Certificate
active
07655233
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.
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Autenrieth Stephen M.
Van Holten Robert W.
Ortho-Clinical Diagnostics, Inc.
Saucier Sandra E
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