Claims for Patent: 3,973,002

Summary for Patent: 3,973,002

Title:	Antihemophilic factor
Abstract:	A quick-dissolving antihemophilic factor preparation is obtained by adjusting the pH of buffer-extracted plasma cryoprecipitate to from about pH 6 to about pH 7.0 and cooling to a temperature of from about 2.degree.C to about 20.degree.C for from about 15 minutes to about 1 hour, in order to precipitate certain protein impurities, primarily fibrinogen.
Inventor(s):	Hagan; James J. (Holmdel, NJ), Glaser; Charles (Raritan, NJ)
Assignee:	E. R. Squibb & Sons, Inc. (Princeton, NJ)
Application Number:	05/573,684
Patent Claims:	1. In a method for isolating antihemophilic factor of human blood plasma, the improvement comprising adjusting the pH of a solution of buffer-extracted plasma cryoprecipitate to from about 6.0 to about 7.0, and cooling the solution at a temperature of from about 2.degree.C to about 20.degree.C for from about 15 to about 60 minutes to cause precipitation of impurities. 2. A method according to claim 1 wherein the solution is held at a temperature of about 15.degree.C and the resulting precipitated impurities are removed. 3. In a method for preparing lyophilized antihemophilic factor of human blood plasma wherein thawed frozen human blood plasma is centrifuged at a temperature of about 0.degree.C to remove a cryoprecipitate, the cryoprecipitate is macerated, the macerated cryoprecipitate is extracted with buffer, the suspension is centifuged and the precipitate is discarded to obtain a buffer extract, the pH of the extract is adjusted to about 7.0-7.2 and the extract is sterilized and lyophilized, the improvement comprising adjusting the pH of the buffer extract to from about pH 6.0 to about pH 7.0, and cooling to a temperature of from about 2.degree.C to about 20.degree.C to precipitate an inert fibrous solid, and removing the precipitate while maintaining the temperature of the extract at a temperature of from about 2.degree.C to about 20.degree.C. 4. A method according to claim 3 wherein the buffer extract is cooled to a temperature of about 15.degree.C and the precipitated impurity is removed. 5. A method according to claim 3 wherein said buffer comprises Tris hydrochloride or sulfate. 6. A method according to claim 3 wherein said buffer comprises a citrate-dextrose buffer. 7. A method according to claim 3 further including the step of mixing the buffer extract, prior to adjusting the pH thereof to 6 - 7, with aluminum hydroxide slurry. 8. A method according to claim 7 further including the improvement of adding sodium citrate to the buffer extract after adjusting the pH thereof to between 6 and 7, and then about neutral to stabilize said buffer extract. 9. A lyophilized antihemophilic factor of human blood plasma prepared according to the method of claim 3. 10. A lyophilized antihemophilic factor of human blood plasma prepared according to the method of claim 8.

Details for Patent 3,973,002

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Therapeutics Llc	KOATE, KOATE-DVI	antihemophilic factor (human)	For Injection	101130	01/24/1974		1994-04-12
Baxalta Us Inc.	HEMOFIL M	antihemophilic factor (human)	For Injection	101448	03/14/2001		1994-04-12
Csl Behring Llc	MONOCLATE, MONOCLATE-P	antihemophilic factor (human)	For Injection	103953	05/14/2003		1994-04-12
Csl Behring Llc	MONOCLATE, MONOCLATE-P	antihemophilic factor (human)	For Injection	103953	03/04/2004		1994-04-12