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Last Updated: March 29, 2024

Claims for Patent: 5,310,878


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Summary for Patent: 5,310,878
Title: Biosynthetic cerebrospinal fluid control and method of use
Abstract:A biosynthetic cerebrospinal fluid control and method of use. Additionally, this invention relates to the isolation and purification of stable liquid human prealbumin, a component in the biosynthetic cerebrospinal fluid control.
Inventor(s): Herring; Kathryn D. (Miami, FL)
Assignee: Baxter Diagnostics Inc. (Deerfield, IL)
Application Number:07/965,456
Patent Claims:1. A method for purifying prealbumin comprising:

(a) diluting human serum with a first buffer;

(b) extracting globulins, ceroplasm and albumin from said human serum of Step (a) after dilution using ion exchange chromatography resulting in at least one fraction containing prealbumin;

(c) isolating said prealbumin containing fractions eluted from Step (b) by immunodiffusion;

(d) pooling said prealbumin containing fractions of Step (c) and concentrating and buffer exchanging said resulting prealbumin containing pooled fraction with a second buffer;

(e) removing albumin from said prealbumin containing pooled fraction of Step (d) affinity chromatography;

(f) isolating the prealbumin containing fractions eluted from Step (e) by immunodiffusion;

(g) pooling said prealbumin containing fractions of Step (e) and concentrating and buffer exchanging said resulting prealbumin containing pooled fraction of Step (f) with a third buffer;

(h) removing globulins from said prealbumin containing pooled fraction of Step (g) by ion exchange chromatography;

(i) pooling, concentrating and buffer exchanging said prealbumin containing fraction of Step (h) with a fourth buffer;

(j) purifying said prealbumin containing fraction of Step (i) by gel filtration to remove any residual proteins;

(k) isolating said purified prealbumin fractions from Step (j); and

(l) pooling, concentrating and sterile filtering said purified prealbumin fractions of Step (k); wherein the method yield is greater than about 60% prealbumin.

2. The method of claim 1 wherein the affinity chromatography media is 1-amino-4-((4-((4-chloro-6-((3(or 4)-sulfophenyl)amino)-1,3,5-triazin-2-yl)amino)-3-sulfophenyl)amino)-9,10- dihydro-9,10-dioxo-2-Anthracenesulfonic acid dye.

3. The method of claim 1 wherein said purified prealbumin fractions of Step (k) are isolated by electrophoresis and immunodiffusion.

4. The method of claim 1 wherein the ion exchange media is selected from the class consisting of diethylaminoethyl crosslinked cellulose ion exchange chromatography media or diethylaminoethyl crosslinked agarose (Pharmacia) ion exchange chromatography media.

5. The method of claim 1 wherein the gel filtration media is a mixture of polyacrylamide and agarose.

Details for Patent 5,310,878

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Grifols Therapeutics Llc ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5 albumin (human) For Injection 101138 10/21/1942 ⤷  Try a Trial 2040-01-28
Baxalta Us Inc. BUMINATE, FLEXBUMIN albumin (human) Injection 101452 03/03/1954 ⤷  Try a Trial 2040-01-28
Csl Behring Ag ALBURX albumin (human) Injection 102366 07/23/1976 ⤷  Try a Trial 2040-01-28
Grifols Biologicals Llc ALBUTEIN albumin (human) Injection 102478 08/15/1978 ⤷  Try a Trial 2040-01-28
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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