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Last Updated: April 20, 2024

Claims for Patent: 10,525,120

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Summary for Patent: 10,525,120

Title:	Methods and compositions for live attenuated viruses
Abstract:	Embodiments herein relate to compositions of and methods for live viruses. In certain embodiments, a live, attenuated virus composition includes, but is not limited to, one or more live, attenuated viruses and compositions to reduce inactivation and/or degradation of the live, attenuated virus. In other embodiments, the live, attenuated virus composition may be a vaccine composition. In yet other compositions, a live, attenuated virus composition may include at least one carbohydrate, at least one protein and at least one high molecular weight surfactants for reducing inactivation and/or degradation of the live, attenuated virus.
Inventor(s):	Stinchcomb; Dan (Fort Collins, CO), Osorio; Jorge E. (Mount Horeb, WI), Wiggan; O\'Neil (Fort Collins, CA)
Assignee:	TAKEDA VACCINES, INC. (Cambridge, MA)
Application Number:	15/194,297
Patent Claims:	1. A virus composition comprising: one or more live, attenuated flaviviruses; and a stabilizing composition comprising serum albumin and trehalose, wherein the one or more live, attenuated flaviviruses consists of one or more Dengue viruses; wherein the serum albumin is serum albumin from a vertebrate species, and is present at a concentration of 0.001 to 3.0% (w/v); wherein the trehalose is present at a concentration of at least 15% (w/v); and wherein the composition is capable of reducing the inactivation of the one or more live, attenuated Dengue viruses. 2. A method for decreasing inactivation of one or more live, attenuated Dengue viruses comprising: combining one or more live, attenuated Dengue viruses with a stabilizing composition comprising serum albumin and trehalose, wherein the serum albumin is serum albumin from a vertebrate species, and is present at a concentration of 0.001 to 3.0% (w/v); wherein the trehalose is present at a concentration of at least 15% (w/v); and wherein the composition is capable of reducing the inactivation of the one or more live, attenuated Dengue viruses. 3. The method of claim 2, further comprising partially or wholly dehydrating the combination. 4. The method of claim 3, further comprising partially or wholly re-hydrating the combination prior to administration. 5. The method of claim 2, wherein the composition increases the shelf life of an aqueous Dengue virus composition. 6. The method of claim 2, wherein the composition decreases inactivation of an aqueous live, attenuated Dengue virus for 24 hours or greater. 7. The method of claim 2, wherein the composition decreases inactivation of an aqueous live, attenuated Dengue virus during one or more freeze and thaw cycles. 8. The method of claim 2, wherein the composition comprises one or more live, attenuated Dengue viruses and is administered to a subject to reduce the onset of a health condition caused by the Dengue viruses. 9. A kit for decreasing inactivation of Dengue viruses comprising: at least one container; and a composition comprising one or more live, attenuated Dengue viruses; and a stabilizing composition comprising: serum albumin and trehalose, wherein the serum albumin is serum albumin from a vertebrate species, and is present at a concentration of 0.001 to 3.0% (w/v); wherein the trehalose is present at a concentration of at least 15% (w/v); and wherein the composition is capable of reducing the inactivation of the one or more live, attenuated Dengue viruses. 10. The kit of claim 9, wherein the serum albumin is human serum albumin. 11. The virus composition of claim 1, wherein the serum albumin is recombinant serum albumin. 12. The virus composition of claim 1, wherein the serum albumin from a vertebrate species is from a human, a canine, or a bovine source. 13. The virus composition of claim 1, wherein the virus composition further comprises one or more poly(ethylene oxide) and poly(propylene oxide) (EO-PO) block copolymers, and the one or more EO-PO block copolymers include poloxamer 407. 14. The virus composition of claim 12, wherein the serum albumin from a vertebrate species is from a human source.

Details for Patent 10,525,120

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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	2027-04-06
Baxalta Us Inc.	BUMINATE, FLEXBUMIN	albumin (human)	Injection	101452	03/03/1954	⤷ Try a Trial	2027-04-06
Csl Behring Ag	ALBURX	albumin (human)	Injection	102366	07/23/1976	⤷ Try a Trial	2027-04-06
Grifols Biologicals Llc	ALBUTEIN	albumin (human)	Injection	102478	08/15/1978	⤷ Try a Trial	2027-04-06
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	02/17/1995	⤷ Try a Trial	2027-04-06
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	06/11/2003	⤷ Try a Trial	2027-04-06
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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