Claims for Patent: 4,780,529

Summary for Patent: 4,780,529

Title:	Isolation of an endotoxin inactivator from human plasma, and methods of use
Abstract:	An endotoxin inactivator is isolated from human plasma by anion exchange (DEAE-Sephadex), dye-affinity (Cibracron Blue-Sepharose), and adsorption (on hydroxyapatite) chromatography. The endotoxin inactivator, isolated in essentially pure form, may be used to depyrogenate clinical blood products.
Inventor(s):	Hao; Yu-Lee (Potomac, MD)
Assignee:	Biotech Research Laboratories, Inc. (Rockville, MD)
Application Number:	07/062,700
Patent Claims:	1. A method of depyrogenating a pyrogenic blood product which comprises providing a pyrogenic blood product, and adding an endotoxin inactivating amount of endotoxin inactivator derived from blood and characterized as follows: (a) a molecular weight of about 61,000 daltons; (b) elution of about 0.2-0.3M NaCl form a DEAE-Sephadex adsorbent; (c) elution at about 01.5-0.25M NaCl from a Cibacron-Blue-Sepharose adsorbent; and (d) elution at about 0.1-0.25M phosphate from a hydroxyapatite adsorbent. 2. The method of claim 1 wherein the endotoxin inactivator is provided in essentially pure form. 3. The method of claim 2, wherein the inactivator is capable of inactivating at least about: 3,657 ng S. typhosa endotoxin, 914 ng S. enteritides endotoxin, or 974 ng E. coli 055:B5 endotoxin, per milligram of endotoxin inactivator. 4. The method of claim 2, wherein the endotoxin inactivator is provided in essentially pure form by subjecting an endotoxin-inactivator-containing fraction of blood to DEAE-sephadex chromatography, immobilized chromophore blue chromatography, and hydroxyapatite chromatography. 5. The method of claim 2 in which the endotoxin inactivator is essentially stable. 6. An essentially nonpyrogenic blood product suitable for parenteral administration consisting essentially of a first blood protein and an essentially stable endotoxin inactivator derived from blood. 7. The product of claim 6 in which the first blood protein is an immunoglobulin. 8. The product of claim 6 in which the first blood protein is antihemophilic factor. 9. The product of claim 6 in which the first blood protein is Factor IX. 10. The product of claim 6 in which the first blood protein is an interferon. 11. A method for the purification of Factor IX complex and endotoxin inactivator from which comprises: (a) subjecting the plasma to DEAE-Sephadex chromatography; (b) eluting the endotoxin inactivator in partially purified from with an eluting buffer containing about 0.2-0.3M NaCl; (c) eluting the Factor IX complex with an eluting buffer containing about 2M NaCl; (d) subjecting the partially purified endotoxin inactivator of step (b) to Cibacron-blue Sepharose chromatography to yield a further purified endotoxin inactivator; and (e) subjecting the further purified endotoxin inactivator of step (d) to hydroxyapatite chromatography to yield endotoxin inactivator in essentially pure form.

Details for Patent 4,780,529

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Biologicals Llc	PROFILNINE, PROFILNINE HP, PROFILNINE HT, PROFILNINE SD	factor ix complex	For Injection	102476	July 20, 1981		2005-10-25