RADIOLABELING AND FORMULATION FOR SCALE UP OF 64Cu-DOTATATE
AssigneeCurium US LLC
InventorsDavid Pipes, Lauren Radford, Shaun Loveless, Allan Casciola
Life of this patent
Estimating the term…
Abstract
The present disclosure relates to methods to create a robust procedure capable of supplying commercial quantities of a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients.
Claims21
A method for radiolabeling DOTATATE comprising the steps of:
- reacting Copper-64 with a buffered solution comprising DOTATATE, [(4,7,10-tricarboxymethyl-1,4,7,10-tetrazacyclododec-1-yl)acetyl]-(D)-phenylalanyl-(L)-cysteinyl-(L)-tyrosyl-(D)-tryptophanyl-(L)-lysyl-(L)-threoninyl-(L)-cysteinyl-(L)-threonine-cylcic disulfide (Cys2-Cys7);
- wherein the reaction occurs in less than 15 minutes at a temperature of less than or equal to 30° C.;
- and
- wherein the mole ratio of total DOTATATE:total Copper-64 is about 125:1 to about 1:1.
A method for preparing a drug product comprising 64Cu-DOTATATE, wherein the drug product is prepared by radiolabeling DOTATATE with Copper-64 at a concentration of about 0.6 μg/mL (μg of DOTATATE per mCi of Copper-64) and wherein the radionuclidic purity of Copper-64 in the drug product is about 99%.
A method for radiolabeling DOTATATE comprising the steps of:
- reacting Copper-64 with a buffered solution comprising DOTATATE;
- wherein the reaction occurs in less than 15 minutes at a temperature of less than or equal to 30° C.;
- and
- wherein DOTATATE can be radiolabeled with Copper-64 at a concentration of about 0.6 μg/mL (μg of DOTATATE per mCi of 64Cu).
Dependencies are inferred from the claim text.