Radiolabeling method
AssigneeRit Oncology, LLC
InventorsPaul Chinn, Ronald A. Morena, Michael J. LaBarre, John E. Leonard
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Abstract
Antibody binding assays and radiolabeling kits are disclosed for radiolabeling and testing therapeutic antibodies in the commercial setting. In particular, the kits are designed for making and evaluating radiolabeled anti-CD20 conjugates to be used for the treatment and imaging of B cell lymphoma tumors. All kit reagents are sterile and are designed to achieve a high level of antibody radiolabeling and product stability with results which are highly reproducible.
Claims27
A method for radiolabeling a chelator-conjugated antibody with 90Y, comprising:
- (i) mixing chelator-conjugated antibody with a solution containing 90Y;
- and
- (ii) incubating the mixture for a time between 3 and 10 minutes at appropriate temperature to produce a radiolabeled antibody having sufficient radioincorporation and specific activity of about 3.2 mCi/mg to about 16.7 mCi/mg, without further purification of the radiolabeled antibody from unincorporated radiolabel.
A method for radiolabeling a chelator-conjugated antibody with 90Y, comprising:
- (i) mixing chelator-conjugated antibody with a solution containing 90Y;
- and
- (ii) incubating the mixture for 3-10 minutes at an appropriate temperature to produce a radiolabeled antibody having sufficient radioincorporation of at least 95%;
- and
- (iii) diluting the radiolabeled antibody to an appropriate concentration in formulation buffer for administration to a human patient without further purification of the radiolabeled antibody from unincorporated radiolabel.
Dependencies are inferred from the claim text.