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Last Updated: April 23, 2024

Claims for Patent: 9,340,619

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Summary for Patent: 9,340,619

Title:	DAC HYP compositions and methods
Abstract:	The present disclosure relates to compositions of daclizumab suitable for subcutaneous administration and methods of manufacturing thereof.
Inventor(s):	Hartman; Taymar E. (Redwood City, CA), Sauer; Paul W. (Fremont, CA), Burky; John E. (Newark, CA), Wesson; Mark C. (San Ramon, CA), Huang; Ping Y. (Fremont, CA), Robinson; Thomas J. (San Mateo, CA), Partridge; Braeden D. (Sunnyvale, CA), Tso; J. Yun (Menlo Park, CA)
Assignee:	AbbVie Biotherapeutics Inc. (Redwood City, CA)
Application Number:	14/671,653
Patent Claims:	1. A composition comprising daclizumab, wherein the daclizumab has an N-linked glycosylation profile determined according to the method described in Section 7.6.14, in which the total AUC of the peaks in the profile corresponding to non-fucosylated mannose glycosyls is less than about 6% of the total AUC of all peaks in the profile. 2. The composition of claim 1, wherein the non-fucosylated mannose glycosyls are Man5, Man 6, and Man7. 3. The composition of claim 2, wherein the N-linked glycosylation profile comprises a Man5 peak wherein the AUC of the Man5 peak constitutes about 3% or less of the total AUC of all peaks in the profile. 4. The composition of claim 1, wherein the composition exhibits less than 30% ADCC average cytotoxicity as measured in an in vitro cellular assay using effector cells from at least 3 healthy donors and KIT225/K6 cells as target cells, at a daclizumab concentration of 1 .mu.g/mL and an effector to target cell ratio of about 25:1.

Details for Patent 9,340,619

Glossary

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Hoffmann-la Roche Inc.	ZENAPAX	daclizumab	Injection	103749	12/10/1997	⤷ Try a Trial	2031-05-27
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	05/27/2016	⤷ Try a Trial	2031-05-27
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	05/26/2017	⤷ Try a Trial	2031-05-27
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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