Claims for Patent: 5,792,838
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Summary for Patent: 5,792,838
Title: | Method for stabilizing immunoglobulin compositions |
Abstract: | The invention relates to a stabilised immunoglobulin composition comprising at least one immunoglobulin together with a stabilising 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 against the CDw52 antigen, most preferably CAMPATH-1H. The invention also relates to a process for enhancing the stability of an immunoglobulin which 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, for example on atomic absorption spectroscopy. |
Inventor(s): | Smith; Marjorie (Beckenham, GB3), Riveros-Rojas; Valentina (Beckenham, GB3) |
Assignee: | Glaxo Wellcome Inc. (Research Triangle Park, NC) |
Application Number: | 08/465,319 |
Patent Claims: | 1. A method of making a stabilized IgG.sub.1 composition comprising adding to a starting composition comprising:
i) IgG.sub.1 and ii) copper ions in an amount sufficient to degrade said IgG.sub.1, an amount of a chelator of copper ions sufficient to stabilize said IgG.sub.1 against copper ion-mediated degradation, so that said stabilization IgG.sub.1 composition is made. 2. A method in accordance with claim 1, wherein the chelator of copper ions is ethylenediamine tetracetic acid. 3. A method in accordance with claim 1, wherein the chelator of copper ions is citrate ion. 4. A method in accordance with claim 2 or 3, wherein the antibody is a recombinant CDR-grafted antibody against the CDw52 antigen. 5. A method in accordance with claim 1, 2 or 3, wherein the antibody is CAMPATH-1H. |
Details for Patent 5,792,838
Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Approval Date | Patent No. | Expiredate |
---|---|---|---|---|---|---|---|
Genzyme Corporation | CAMPATH | alemtuzumab | Injection | 103948 | 05/07/2001 | ⤷ Try a Trial | 2015-08-11 |
Genzyme Corporation | LEMTRADA | alemtuzumab | Injection | 103948 | 11/14/2014 | ⤷ Try a Trial | 2015-08-11 |
Genzyme Corporation | CAMPATH | alemtuzumab | Injection | 103948 | 10/12/2004 | ⤷ Try a Trial | 2015-08-11 |
>Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Approval Date | >Patent No. | >Expiredate |
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