Claims for Patent: 7,229,620
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Summary for Patent: 7,229,620
Title: | Method for radiolabeling antibodies with yttrium-90 |
Abstract: | Methods and kits for radiolabeling proteins, peptides and ligands with radiolytic isotopes, particularly yttrium-90, are disclosed, whereby sufficient purity, specific activity and binding affinity are achieved such that the radiolabeled protein may be directly administered to a patient without further column purification. Such kits and methods will be particularly useful in bringing radioimmunotherapy to the hospital and outpatient setting for the treatment of cancer. |
Inventor(s): | Chinn; Paul (Carlsbad, CA) |
Assignee: | Biogen Idec Inc. (Cambridge, MA) |
Application Number: | 11/181,811 |
Patent Claims: | 1. A method for radiolabeling a chelator-conjugated antibody or antibody fragment with .sup.90Y for administration to a patient comprising: (i) mixing the chelator-conjugated
antibody or antibody fragment with a solution comprising .sup.90Y or a salt thereof, and (ii) incubating the mixture for a sufficient amount of time under amiable conditions such that a .sup.90Y-labeled antibody or antibody fragment is produced having
sufficient radioincorporation, immunoreactivity of at least 50%, and a specific activity of at least about 5 mCi/mg, such that the .sup.90Y-labeled antibody or antibody fragment may be administered directly to the patient without further purification of
the .sup.90Y-labeled radiolabeled antibody or antibody fragment from unincorporated .sup.90Y; wherein said chelator is a bifunctional chelator selected from the group consisting of MX-DTPA, phenyl-DTPA, benzyl-DTPA, CHX-DTPA, DOTA and derivatives
thereof.
2. The method of claim 1, wherein said amiable conditions refer to acceptable temperature, pH and buffer conditions. 3. The method of claim 2, wherein said acceptable temperature ranges from about 25.degree. C. to about 50.degree. C. 4. The method of claim 2, wherein said acceptable pH ranges from about 3 to about 6. 5. The method of claim 2, wherein said acceptable buffer is an acetate buffer and is at a concentration of between about 10 and about 1000 mM. 6. The method of claim 1, wherein said sufficient incubation time is less than about eight minutes. 7. The method of claim 6, wherein said sufficient incubation time is between about 30 seconds to about five minutes. 8. The method of claim 1, wherein the specific activity of the .sup.90Y-labeled antibody or antibody fragment is greater than 10 mCi/mg. 9. The method of claim 8, wherein the specific activity of the .sup.90Y-labeled antibody or antibody fragment is at least 15 mCimg. 10. The method of claim 1, wherein a level of radioincorporation of greater than 95% is achieved. 11. The method of claim 1, wherein a level of radioincorporation of greater than 96% is achieved. 12. The method of claim 1, wherein the immunoreactivity is at least 70%. 13. The method of claim 1, wherein the immunoreactivity is at least 80%. 14. The method of claim 1, wherein the chelator is MX-DTPA. 15. The method of claim 1, wherein the ratio of chelator to antibody or antibody fragment ranges from 11/2 to 1. 16. The method of claim 1, wherein the antibody or antibody fragment binds specifically to CD20. 17. The method of claim 16, wherein the antibody is 2B8. 18. The method of claim 17, wherein the chelator is MX-DTPA. 19. The method of claim 1, wherein the antibody fragment is selected from the group consisting of Fab, F(ab').sub.2, and Fv fragments. 20. A method for radiolabeling a MX-DTPA-conjugated 2B8 antibody or antibody fragment with .sup.90Y for administration to a patient comprising: (i) mixing the MX-DTPA-conjugated antibody or antibody fragment with a solution comprising .sup.90Y or a salt thereof, and (ii) incubating the mixture for a sufficient amount of time under acceptable temperature, pH and buffer conditions such that a .sup.90Y-labeled antibody or antibody fragment is produced having sufficient radioincorporation, immunoreactivity of at least 50% , and a specific activity of at least about 5 mCi/mg, such that the .sup.90Y-labeled antibody or antibody fragment may be administered directly to the patient without further purification of the .sup.90Y-labeled 2B8 antibody or antibody fragment from unincorporated .sup.90Y. |
Details for Patent 7,229,620
Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Approval Date | Patent No. | Expiredate |
---|---|---|---|---|---|---|---|
Acrotech Biopharma Llc | ZEVALIN | ibritumomab tiuxetan | Injection | 125019 | 02/19/2002 | ⤷ Try a Trial | 2019-03-01 |
>Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Approval Date | >Patent No. | >Expiredate |
International Patent Family for US Patent 7,229,620
Country | Patent Number | Estimated Expiration |
---|---|---|
South Africa | 200106945 | ⤷ Try a Trial |
Yugoslavia | 61701 | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 0052031 | ⤷ Try a Trial |
United States of America | 7618613 | ⤷ Try a Trial |
United States of America | 6994840 | ⤷ Try a Trial |
United States of America | 2007297978 | ⤷ Try a Trial |
United States of America | 2006067884 | ⤷ Try a Trial |
>Country | >Patent Number | >Estimated Expiration |
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