IP Library › Granted Patent US 9,340,619
Granted Patent B2
US 9,340,619 · App. 14/671,653 · Granted May 17, 2016

DAC HYP compositions and methods

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Quick Facts
Patent No.
US 9,340,619
App. No.
14/671,653
Granted
May 17, 2016
Kind
B2
Abstract

The present disclosure relates to compositions of daclizumab suitable for subcutaneous administration and methods of manufacturing thereof.

Claims (4)

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 μg/mL and an effector to target cell ratio of about 25:1.