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Last Updated: April 24, 2024

Claims for Patent: 4,990,447

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Summary for Patent: 4,990,447

Title:	Process for the purification of serum albumin
Abstract:	Recombinantly produced serum albumin is purified in a series of steps, initially employing an alkaline precipitation, optionally followed by incubation with an anion exchange absorbent, followed by affinity chromatography employing a hydrophobic solid phase and using a water-soluble lipid anion as desorbens in the aqueous phase.
Inventor(s):	Konig; Boudewijn W. (Amsterdam, NL), Hamers; Michiel N. (Amsterdam, NL), van der Laken; Cornelis J. (Leiden, NL)
Assignee:	Gist-Brocades NV (Delft, NL)
Application Number:	07/317,818
Patent Claims:	1. A method for producing purified recombinant serum albumin at least substantially free of contaminants from a host microorganism comprising: growing in a medium microorganisms transformed with an expression construct comprising a structural gene encoding serum albumin, whereby serum albumin is expressed; isolating a product medium as a clarified fermentation broth or cell lysate; making the product medium alkaline to produce a precipitate without the addition of additional agents and separating, said alkaline medium from said precipitate; changing the pH of said alkaline medium to about physiologic pH to provide an aqueous phase comprising concentrated serum albumin and chromatographing said aqueous phase with a lipophilic immobile phase and eluting the albumin by adding as desorbens a water soluble lipid anion to said aqueous phase; and isolating purified serum albumin at least substantially free of contaminants from said microorganism. 2. A method according to claim 1, said method further comprising prior to said chromatographing, acidifying said alkaline medium and incubating the resulting acidified medium with an anion exchange resin. 3. A method according to claim 2, wherein said acidified medium is at a pH in the range of 4.0 to 5.5. 4. A method according to claim 2, including the additional step of dialyzing said acidified medium after said incubation. 5. A method according to claim 3, including the additional step of dialyzing said acidified medium after said incubation. 6. A method according to claim 1, wherein said alkaline medium is at a pH in the range of about 7.5-9.0. 7. A method according to claim 2, wherein said alkaline medium is at a pH in the range of about 7.5-9.0. 8. A method according to claim 4, wherein said alkaline medium is at a pH in the range of about 7.5-9.0. 9. A method according to claim 1, wherein said desorbens has an alkyl group of from about 6 to 12 carbon atoms. 10. A method according to claim 2, wherein said desorbens has an alkyl group of from about 6 to 12 carbon atoms. 11. A method according to claim 4, wherein said desorbens has an alkyl group of from about 6 to 12 carbon atoms. 12. A method according to claim 9, wherein said desorbens is a carboxylate of from about 6 to 12 carbon atoms. 13. A method according to claim 1, wherein said desorbens is a carboxylate of from about 6 to 12 carbon atoms. 14. A method according to claim 1, including the additional step of dialyzing said purified serum albumin. 15. A method according to claim 2, including the additional step of dialyzing said purified serum albumin. 16. A method according to claim 4, including the additional step of dialyzing said purified serum albumin. 17. A method according to claim 1, wherein said microorganism is a yeast. 18. A method according to claim 2, wherein said microorganism is a yeast. 19. A method according to claim 4, wherein said microorganism is a yeast. 20. A method according to claim 14, wherein said microorganism is a yeast. 21. A method according to claim 1, wherein said serum albumin is human serum albumin. 22. A method according to claim 2, wherein said serum albumin is human serum albumin. 23. A method according to claim 4, wherein said serum albumin is human serum albumin. 24. A method according to claim 14, wherein said serum albumin is human serum albumin. 25. A method according to claim 17, wherein said serum albumin is human serum albumin.

Details for Patent 4,990,447

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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
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	02/17/1995	⤷ Try a Trial	2040-01-28
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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