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

Inactive Publication Date: 2007-03-01
PLASMA TECH LLC
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  • Abstract
  • Description
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Benefits of technology

[0025] In summary, the process of the instant invention employs high concentrations of sodium citrate combined with its subsequent removal from the gamma globulin concentrate by means of diafiltration, a technique which became practical on an industrial scale in the 1980's. Final purification of the resulting gamma globulin is then practically and effectively achieved through the use of well-established chromatographic purification techniques. The invention reduces production costs as a result of higher yields, fewer fractionation steps, shorter overall processing time, lower energy costs, and lower chemical costs. Capital cost

Problems solved by technology

Even so, the use of alcohol precipitants is not without difficulties, as illustrated by Cohn, “Some protein precipitants, such as alcohol, have a tendency to denature many proteins with which they come in contact, the danger of denaturat

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  • Ultra-high yield intravenous immune globulin preparation
  • Ultra-high yield intravenous immune globulin preparation
  • Ultra-high yield intravenous immune globulin preparation

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Embodiment Construction

[0036] Reference is now made to flow path elements illustrated in FIGS. 1-4. Generally, each rectangular box is used to illustrate a procedural step; each diamond is used to demonstrate a separation step; each elliptical cylinder designates a product resulting from a preceding procedural or separation step; and each circle is used to identify either a starting point or an off-sheet continuation path point.

[0037] Reference is now made to FIG. 1 wherein an initial portion 10-1 of an preferred IgG process flow path, generally numbered 10, is seen. As indicated after initial starting point 20, a volume of plasma 30 to be processed is selected for processing. It should be noted that while plasma 30 is used by example in this description of an illustrated embodiment, other blood-based products may be processed within the scope of the instant invention.

[0038] As part of procedure 40, selected frozen plasma 30 is warmed to approximately five degrees Centigrade to form prepared plasma 50. ...

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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.

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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Application Information

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IPC IPC(8): C07K16/18C07K14/765
CPCC07K14/765A61P7/00
Inventor ZURLO, EUGENE J.CURTIN, DENNISLOUDERBACK, ALLAN L.
Owner PLASMA TECH LLC
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