Ultra-high Yield Intravenous Immune Globulin Preparation

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 one or more salts from a group of salts comprising sodium citrate, sodium acetate, sodium gluconate, ammonium sulfate, sodium chloride, sodium sulfate and ammonium chloride in two initial fractionation steps, followed by diafiltration to remove those salts employed. A process which employs alcohol via the process of the disclosed inventive method is also disclosed.

Description

[0001]This Application for Patent is a Divisional of U.S. patent application Ser. No. 11 / 358,431, filed Feb. 21, 2006, which is a Continuation-in-Part of U.S. patent application Ser. No. 11 / 232,527, filed Sep. 22, 2005, which is a Continuation-in-Part of U.S. patent application Ser. No. 11 / 217,956, filed Sep. 1, 2005.FIELD OF INVENTION[0002]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. Interestingly, the method of the instant invention also may be employed using alcohol.BACKGROUND AND DESCRIPTION OF RELATED ART[0003]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. Samo, et al. (SARNO), “One scheme in widespread use is the well-known Cohn fr...

AI Technical Summary

Benefits of technology

"The invention provides a novel and effective method for isolating gamma globulin from plasma and formulating it into an intravenous immune globulin preparation. This is achieved by using specific salts to precipitate the gamma globulin from the plasma, resulting in a higher yield and quality compared to previous methods. The use of these salts does not require a specific molar reaction, but rather a simple percentage by weight relationship. The method involves adding a first measure of salt to the plasma, allowing it to separate into a supernatant and a residual paste. A second measure of salt is then added to the supernatant to form a second separable product. The second product is then diluted and diafiltered to remove excess salt. The resulting product is a low volume, ready for further processing. The invention also provides a faster and more efficient method for isolating and formulating the gamma globulin compared to existing methods."

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 denaturation increasing with concentration of the alcohol and increase in temperature.

Such binding may be a cause of changes in protein configuration resulting in some permanent denaturation of protein molecules which remains after ethanol is removed and water is returned.

However, chromatographic separation of the large-weight, lower-value fractions such as albumin and gamma globulin, on an industrial scale has not been found to be practical.

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