Claims for Patent: 10,449,118

Summary for Patent: 10,449,118

Title:	Manufacture of peanut formulations for oral desensitization
Abstract:	The present application relates to a method for managing the development and manufacturing process of a therapeutically effective formulation. Peanut proteins are characterized from peanut flour and encapsulated formulations made using the peanut flour for oral immunotherapy of peanut allergies.
Inventor(s):	Walser; Bryan (Menlo Park, CA), Raff; Howard V. (Mill Valley, CA)
Assignee:	AIMMUNE THERAPEUTICS, INC. (Brisbane, CA)
Application Number:	15/792,716
Patent Claims:	1. A method of making an allergenic peanut flour formulation, comprising: (a) providing defatted peanut flour; (b) characterizing a concentration of each of Ara h1, Ara h2, and Ara h6 in the defatted peanut flour; and (c) mixing the defatted peanut flour comprising the characterized concentration of each of Ara h1, Ara h2, and Ara h6 with a lubricant, a glidant, or a diluent to form the allergenic peanut flour formulation. 2. The method of claim 1, wherein characterizing the concentration of each of Ara h1, Ara h2, and Ara h6 in the defatted peanut flour comprises determining a relative concentration of each of Ara h1, Ara h2, and Ara h6 compared to a total peanut protein content in the defatted peanut flour. 3. The method of claim 1, wherein characterizing the concentration of each of Ara h1, Ara h2, and Ara h6 in the defatted peanut flour comprises determining a relative concentration of each of Ara h1, Ara h2, and Ara h6 compared to each other in the defatted peanut flour. 4. The method of claim 1, wherein the concentration of each of Ara h1, Ara h2, and Ara h6 are characterized by Reverse Phased-High Performance Liquid Chromatography (RP-HPLC). 5. The method of claim 1, further comprising monitoring lot-to-lot consistency of Ara h1, Ara h2, and Ara h6. 6. The method of claim 1, further comprising packaging the allergenic peanut flour formulation in a pharmaceutical dosage form. 7. The method of claim 6, wherein the pharmaceutical dosage form comprises about 0.5 mg to about 1000 mg of peanut protein. 8. The method of claim 1, further comprising encapsulating the allergenic peanut flour formulation in a capsule. 9. The method of claim 8, wherein the capsule comprises about 0.5 mg to about 1000 mg of peanut protein. 10. The method of claim 1, wherein the defatted peanut flour is about 10% to about 15% defatted peanut flour. 11. The method of claim 1, wherein the defatted peanut flour is about 12% defatted peanut flour. 12. The method of claim 1, further comprising discharging the allergenic peanut flour formulation. 13. The method of claim 1, further comprising passing the allergenic peanut flour formulation through a mesh screen. 14. A method of making an allergenic peanut flour formulation, comprising: (a) mixing a defatted peanut flour with a lubricant, a glidant, or a diluent to form the allergenic peanut flour formulation; and (b) characterizing a concentration of each of Ara h1, Ara h2, and Ara h6 in the allergenic peanut flour formulation. 15. The method of claim 14, wherein characterizing the concentration of each of Ara h1, Ara h2, and Ara h6 in the allergenic peanut flour formulation comprises determining a relative concentration of each of Ara h1, Ara h2, and Ara h6 compared to a total peanut protein content in the peanut flour formulation. 16. The method of claim 14, wherein characterizing the concentration of each of Ara h1, Ara h2, and Ara h6 in the allergenic peanut flour formulation comprises determining a relative concentration of each of Ara h1, Ara h2, and Ara h6 compared to each other in the allergenic peanut flour formulation. 17. The method of claim 14, wherein the concentration of each of Ara h1, Ara h2, and Ara h6 are characterized by Reverse Phased-High Performance Liquid Chromatography (RP-HPLC). 18. The method of claim 14, further comprising monitoring lot-to-lot consistency of Ara h1, Ara h2, and Ara h6. 19. The method of claim 14, further comprising packaging the allergenic peanut flour formulation in a pharmaceutical dosage form. 20. The method of claim 19, wherein the pharmaceutical dosage form comprises about 0.5 mg to about 1000 mg of peanut protein. 21. The method of claim 14, further comprising encapsulating the allergenic peanut flour formulation in a capsule. 22. The method of claim 21, wherein the capsule comprises about 0.5 mg to about 1000 mg of peanut protein. 23. The method of claim 14, wherein the defatted peanut flour is about 10% to about 15% defatted peanut flour. 24. The method of claim 14, wherein the defatted peanut flour is about 12% defatted peanut flour. 25. The method of claim 14, further comprising discharging the allergenic peanut flour formulation. 26. The method of claim 14, further comprising passing the allergenic peanut flour formulation through a mesh screen.

Details for Patent 10,449,118

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Aimmune Therapeutics, Inc.	PALFORZIA	peanut (arachis hypogaea) allergen powder-dnfp	Powder	125696	January 31, 2020		2037-10-24