Claims for Patent: 9,448,147
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Summary for Patent: 9,448,147
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: | 14/074,807 |
Patent Claims: | 1. A method of monitoring production of a glycoprotein, the method comprising: producing a glycoprotein in a cell culture; removing at least a first and second sample of the
glycoprotein, wherein the samples include at least one charged N-glycan; adding a known quantity of a reference N-glycan to the samples, wherein the reference N-glycan is labeled with a labeling agent; for each of the first and second samples: (i)
separating the sample by anion-exchange chromatography to generate a plurality of fractions; (ii) separating a first portion of the plurality of fractions by at least one secondary chromatographic technique to obtain first separated fractions; (iii)
separating a second portion of the plurality of fractions by at least one secondary chromatographic technique that differs from the secondary chromatographic technique from (ii) to obtain second separated fractions; (iv) 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; and comparing the result of (iv) from the first sample with that for the second
sample.
2. The method of claim 1, wherein the at least one secondary chromatographic technique from (ii) is selected from the group consisting of reversed phase liquid chromatography (RP), normal phase liquid chromatography (NP), ion-pairing reverse phase chromatography (IP-RP), size exclusion chromatography, affinity chromatography (AC), capillary electrophoresis (CE); fluorophore-assisted carbohydrate electrophoresis (FACE); electrochromatography, and micellar electrokinetic chromatography (MEKC). 3. The method of claim 1, wherein the at least one secondary chromatographic technique from (ii) is a reversed phase chromatographic technique. 4. The method of claim 3, wherein the reversed-phase chromatographic technique employs a C18 reverse phase resin. 5. The method of claim 3, wherein the reversed-phase chromatographic technique employs a porous graphitized-carbon (PGC) resin. 6. The method of claim 1, wherein the at least one secondary chromatographic technique from (ii) is a normal phase chromatographic technique. 7. The method of claim 6, wherein the normal phase chromatographic technique employs a modified silica gel. 8. The method of claim 7, wherein the modified silica gel is selected from the group consisting of cyano-modified silica, amine-modified silica, and amide-modified silica. 9. The method of claim 1, wherein the at least one secondary chromatographic technique from (iii) is selected from the group consisting of reversed phase liquid chromatography (RP), normal phase liquid chromatography (NP), ion-pairing reverse phase chromatography (IP-RP), size exclusion chromatography, affinity chromatography (AC), capillary electrophoresis (CE); fluorophore-assisted carbohydrate electrophoresis (FACE); electrochromatography, and micellar electrokinetic chromatography (MEKC). 10. The method of claim 1, wherein the at least one secondary chromatographic technique from (iii) is a reversed phase chromatographic technique. 11. The method of claim 10, wherein the reversed-phase chromatographic technique employs a resin selected from the group consisting of a C18 reverse phase resin and a porous graphitized-carbon (PGC) resin. 12. The method of claim 1, wherein the at least one secondary chromatographic technique from (iii) is a normal phase chromatographic technique. 13. The method of claim 12, wherein the normal phase chromatographic technique employs a modified silica gel. 14. The method of claim 13, wherein the modified silica gel is selected from the group consisting of cyano-modified silica, amine-modified silica, and amide-modified silica. 15. The method of claim 1, wherein the at least one secondary chromatographic technique from (ii) is a normal phase chromatographic technique and the at least one secondary chromatographic technique from (iii) is a reverse phase chromatographic technique. 16. The method of claim 1, wherein the first portion of the plurality of fractions comprises the first half to two-thirds of the fractions from the anion exchange chromatography. 17. The method of claim 1, wherein the second portion of the plurality of fractions comprises the second half to one-third of the fractions from the anion exchange chromatography. 18. The method of claim 1, wherein the glycoprotein is a therapeutic glycoprotein. 19. The method of claim 18, wherein the therapeutic glycoprotein is an antibody. 20. The method of claim 19, wherein the antibody is a preparation of alemtuzumab, etanercept, adalimumab, abatacept, infliximab, bevacizumab, rituximab, natalizumab, or cetuximab. |
Details for Patent 9,448,147
Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Approval Date | Patent No. | Expiredate |
---|---|---|---|---|---|---|---|
Genentech, Inc. | RITUXAN | rituximab | Injection | 103705 | 11/26/1997 | ⤷ Try a Trial | 2027-04-16 |
Idec Pharmaceuticals Corp. | RITUXAN | rituximab | Injection | 103737 | 02/19/2002 | ⤷ Try a Trial | 2027-04-16 |
Janssen Biotech, Inc. | REMICADE | infliximab | For Injection | 103772 | 08/24/1998 | ⤷ Try a Trial | 2027-04-16 |
Immunex Corporation | ENBREL | etanercept | For Injection | 103795 | 11/02/1998 | ⤷ Try a Trial | 2027-04-16 |
Immunex Corporation | ENBREL | etanercept | For Injection | 103795 | 05/27/1999 | ⤷ Try a Trial | 2027-04-16 |
Immunex Corporation | ENBREL | etanercept | Injection | 103795 | 09/27/2004 | ⤷ Try a Trial | 2027-04-16 |
>Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Approval Date | >Patent No. | >Expiredate |
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