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Last Updated: May 10, 2024

Claims for Patent: 5,654,403

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Summary for Patent: 5,654,403

Title:	Immunoglobulins stabilized with a chelator of copper ions
Abstract:	A stabilized immunoglobulin composition comprises at least one immunoglobulin together with a stabilizing amount of a chelator of copper ions such as EDTA or citrate. Preferably the immunoglobulin is an antibody, for example, a recombinant CDR-grafted antibody. A process for enhancing the stability of an immunoglobulin comprises subjecting the immunoglobulin to a purification procedure capable of removing copper ions therefrom. Preferably, the immunoglobulin is rendered substantially free from detectable copper ions as determined, for example, by atomic absorption spectroscopy.
Inventor(s):	Smith; Marjorie (Beckenham, GB3), Riveros-Rojas; Valentina (Beckenham, GB3)
Assignee:	Burroughs Wellcome Co. (Research Triangle Park, NC)
Application Number:	08/232,127
Patent Claims:	1. In an immunoglobulin composition of IgG.sub.1 containing copper ions in an amount sufficient to degrade the immunoglobulin, wherein the improvement comprises the addition of an amount of a chelator of copper ions sufficient to bind the copper ions present in the composition and protect the immunoglobulin from degradation by the copper ions and thus stabilize the IgG.sub.1 composition. 2. A composition in accordance with claim 1, wherein the immunoglobulin is a recombinant immunoglobulin. 3. A composition in accordance with claim 2, wherein the immunoglobulin is a chimetic or humanized immunoglobulin. 4. A composition in accordance with claim 2 or 3, wherein the immunoglobulin is produced from a Chinese hamster ovary (CHO) cell. 5. A composition in accordance with claim 2 or 3, wherein the immunoglobulin is produced from a myeloma cell. 6. A composition in accordance with claim 1, 2 or 3, wherein the immunoglobulin specifically binds to a tumor cell marker antigen. 7. A composition in accordance with claim 1, 2 or 3, wherein the immunoglobulin specifically binds to the CD2, CD3 CD4, CD5, CD7, CD8, CD11a, CD11b, CD18, CD19, CD25, CDw52, CD33 or CD54 antigen. 8. A composition in accordance with claim 1, 2 or 3, wherein the chelator is ethylenediamine tetraacetic acid (EDTA). 9. A composition in accordance with claim 8, wherein the amount of EDTA is 0.05 mM to 5 mM. 10. A composition in accordance with claim 9, wherein the amount of EDTA is 0.1 mM to 3 mM. 11. A composition in accordance with claim 1, 2 or 3, wherein the chelator is citrate ion. 12. A composition in accordance with claim 11, wherein the citrate ion is alkali metal citrate. 13. A composition in accordance with claim 1, 2 or 3, wherein the pH of the composition is within the range of 6 to 7.2. 14. A composition in accordance with claim 1, which is in the form of a liquid preparation suitable for parenteral administration. 15. A composition in accordance with claim 1, which is in lyophilized form suitable for reconstitution into a liquid preparation suitable for parenteral administration. 16. A stabilized immunoglobulin composition comprising an IgG.sub.1 and copper ions, wherein the copper is present in an amount sufficient to degrade the immunoglobulin, together with an amount of a chelator of copper ions sufficient to bind the copper ions present in the composition and protect the immunoglobulin from degradation by the copper ions.

Details for Patent 5,654,403

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	05/07/2001	⤷ Try a Trial	2014-08-05
Genzyme Corporation	LEMTRADA	alemtuzumab	Injection	103948	11/14/2014	⤷ Try a Trial	2014-08-05
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	10/12/2004	⤷ Try a Trial	2014-08-05
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

International Patent Family for US Patent 5,654,403

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Country	Patent Number	Estimated Expiration
South Africa	9208296	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	9308837	⤷ Try a Trial
United States of America	5792838	⤷ Try a Trial
Singapore	47905	⤷ Try a Trial
>Country	>Patent Number	>Estimated Expiration

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