Ultra-high yield intravenous immune globulin preparation

a high-quality, intravenous technology, applied in the direction of extracellular fluid disorder, drug composition, peptide, etc., can solve the problems of inability to realize industrial scale practicality, increase in temperature, and inability to separate large-weight fractions such as albumin and gamma globulin, so as to reduce production costs, less fractionation steps, and high yield
US20070049732A1Inactive Publication Date: 2007-03-01PLASMA TECH LLC
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Patent Information

Authority / Receiving Office
US · United States
Current Assignee / Owner
PLASMA TECH LLC
Publication Date
2007-03-01
Estimated Expiration
Not applicable · inactive patent

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Abstract

An efficacious large-scale alcohol-free plasma fractionation production process which produces a high-yielding, non-denatured, double viral-inactivated intravenous human immune gamma globulin (IgG) product. The process employs sodium citrate in two initial fractionation steps, followed by diafiltration to remove sodium citrate.
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Description

FIELD OF INVENTION

[0001] This invention relates generally to methods for immune serum globulin purification, and, more particularly, to methods for alcohol-free separation of immune globulin from blood plasma or other blood based material. BACKGROUND AND DESCRIPTION OF RELATED ART

[0002] Commonly, contemporary methods for separation of immune globulins (IgG) from blood plasma or other blood based material depend upon early work by Edwin J. Cohn. As found in U.S. Pat. No. 5,177,194 issued Jan. 5, 1993 to Maria E. Sarno, et al. (SARNO), “One scheme in widespread use is the well-known Cohn fractionation method, which is based on differential precipitation using cold ethanol.” Cohn et al. J. Am. Chem. Soc. 68, 459 (1946).

[0003] A U.S. Pat. No. 2,390,074 issued Dec. 4, 1945 to Edwin J. Cohn (Cohn) disclosed use of alcohol, acetone and dioxane as precipitants in such fractionation processes. Continued dependence upon alcohol as a precipitant is further demonstrated in U.S. Pat. No. 6,89...

Claims

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