Claims for Patent: 10,317,410

Summary for Patent: 10,317,410

Title:	Multi-dimensional chromatographic methods for separating N-glycans
Abstract:	A multi-dimensional chromatographic method for the separation of N-glycans. The method comprises providing a glycan preparation that includes at least one negatively charged N-glycan. The glycan preparation is then separated by anion-exchange chromatography and at least one secondary chromatographic technique.
Inventor(s):	Parsons; Ian Christopher (Belmont, MA), Zheng; Ting (Lake Oswego, OR), Gunay; Nur Sibel (Chestnut Hill, MA), Bosques; Carlos J. (Arlington, MA)
Assignee:	Momenta Pharmaceuticals, Inc. (Cambridge, MA)
Application Number:	15/480,786
Patent Claims:	1. A method of characterizing a mixture of N-glycans, the method comprising steps of: (i) providing a glycan preparation from an adalimumab preparation, wherein the glycan preparation includes at least one charged N-glycan and a known quantity of a reference N-glycan, wherein the reference N-glycan is labeled with a labeling agent; (ii) separating the glycan preparation by anion-exchange chromatography to generate a plurality of sample fractions; (iii) separating a first portion of the plurality of sample fractions by at least one secondary chromatographic technique to obtain first separated fractions; (iv) separating a second portion of the plurality of sample fractions by at least one secondary chromatographic technique that differs from the secondary chromatographic technique from (iii) to obtain second separated fractions; and (v) quantifying at least one N-glycan relative to the reference N-glycan in at least a portion of the first separated fractions, or in at least a portion of the second separated fractions, or both. 2. The method of claim 1, wherein the adalimumab preparation is obtained from a culture of cells producing adalimumab. 3. The method of claim 2, further comprising a step of comparing the result from (v) with that of a reference sample. 4. The method of claim 3, wherein the reference sample is a glycan preparation obtained from a different batch of cells producing adalimumab. 5. The method of claim 3, wherein the reference sample is a glycan preparation obtained from the culture of cells at a different time than the adalimumab preparation. 6. The method of claim 3, further comprising a step of recording the result of the comparing in a quality control record for the adalimumab preparation. 7. The method of claim 3, wherein the result from (v) is compared with a historical record of the reference sample.

Details for Patent 10,317,410

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002		2027-04-16
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008		2027-04-16
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013		2027-04-16