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Last Updated: April 26, 2024

Claims for Patent: 9,845,338

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Summary for Patent: 9,845,338

Title:	Method of purifying an antibody
Abstract:	A method of purifying an antibody composition comprises application of anion exchange chromatography late in the purification process. An ultrafiltration/diafiltration-purified antibody composition is subjected to anion exchange chromatography (AEX) to form a pharmaceutically-pure antibody composition.
Inventor(s):	Kokke; Bastiaan Pieter Arjan (Nijmegen, NL), Wijk-Basten Van; Everdina Josephina Wilhelmina (Nijmegen, NL), Beijer De; Thomas Antonius Bernardus (Nijmegen, NL), Marza Perez; Maria (Nijmegen, NL), Eppink; Michel Hendrikus Maria (Nijmegen, NL)
Assignee:	Synthon Biopharmaceuticals BV (Nijmegen, NL)
Application Number:	14/410,562
Patent Claims:	1. A method of purifying an antibody composition, wherein the antibody is produced in eukaryotic cells, which comprises subjecting a UF/DF-purified antibody composition to anion exchange chromatography (AEX) to form a pharmaceutically-pure antibody composition, wherein said anion exchange chromatography is the last chromatographic purification step and is performed directly after the final UF/DF step. 2. The method of claim 1, wherein said UF/DF-purified antibody composition has an antibody concentration of at least 1 mg/ml. 3. The method of claim 2, wherein said UF/DF-purified antibody composition has an antibody concentration of at least 10 mg/ml. 4. The method of claim 3, wherein said UF/DF-purified antibody composition has an antibody concentration of not greater than 250 mg/ml. 5. The method of claim 4, wherein said UF/DF-purified antibody composition has an antibody concentration of 20 to 50 mg/ml. 6. The method of claim 1, which further comprises filling said pharmaceutically-pure antibody composition into vials. 7. The method according to claim 6, which further comprises aseptically filtering said pharmaceutically-pure antibody composition prior to said filling step. 8. The method according to claim 7, which further comprises at least one of the following steps prior to said filling step: (a) adding an excipient to said pharmaceutically-pure antibody composition; (b) concentrating said pharmaceutically-pure antibody composition; (c) diluting said pharmaceutically-pure antibody composition; and/or (d) adjusting the pH of said pharmaceutically-pure antibody composition. 9. The method of claim 1, wherein said UF/DF-purified antibody composition is obtained by subjecting a partially-purified antibody composition to UF/DF. 10. The method of claim 9, wherein an antibody cell culture harvest is subjected to an antibody capture step and optionally at least one polishing step to form said partially-purified antibody composition. 11. The method of claim 10, wherein said capture step utilizes affinity chromatography. 12. The method of claim 11, wherein said affinity chromatography is Protein A chromatography. 13. The method of claim 10, wherein said capture step utilizes cation exchange chromatography (CEX), hydrophobic charge induction chromatography (HCIC), or mixed mode chromatography. 14. The method of claim 10, wherein at least one polishing step is carried out after said capture step. 15. The method according to claim 14, wherein said at least one polishing step is selected from the group consisting of ion exchange chromatography (IEX), hydrophobic interaction chromatography (HIC), and hydroxyapatite chromatography. 16. The method of claim 1, wherein said antibody is trastuzumab or pertuzumab. 17. The method of claim 1, wherein said antibody was produced in CHO cells. 18. A method of purifying an antibody composition, which comprises: subjecting an antibody eukaryotic cell culture harvest to affinity chromatography to capture a crude antibody composition; subjecting the crude antibody composition to at least one polishing step to form a partially-purified antibody composition; subjecting the partially-purified antibody composition to a UF/DF step to form a UF/DF-purified antibody composition; and subjecting the UF/DF-purified antibody composition to anion exchange chromatography (AEX) to form a pharmaceutically-pure antibody composition, wherein said anion exchange chromatography is the last chromatographic purification step and is performed directly after the final UF/DF step. 19. The method of claim 18, wherein said affinity chromatography is Protein A chromatography. 20. The method of claim 18, which further comprises subjecting said pharmaceutically-pure antibody composition to a virus removal step. 21. The method of claim 20, wherein said virus removal step is nanofiltration. 22. The method of claim 18, wherein said at least one polishing step comprises subjecting said crude antibody composition to at least one ionic exchange chromatography (IEX) step.

Details for Patent 9,845,338

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998	⤷ Try a Trial	2039-02-26
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017	⤷ Try a Trial	2039-02-26
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409	06/08/2012	⤷ Try a Trial	2039-02-26
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019	⤷ Try a Trial	2039-02-26
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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