Radiolabeling and formulation for scale up of 64Cu-DOTATATE
AssigneeCurium US LLC
InventorsDavid Pipes, Lauren Radford, Shaun Loveless, Allan Casciola
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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.
Claims7
A drug product for use in positron emission tomography comprising 64Cu-DOTATATE (64Cu—N-[(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 drug product comprises a molar ratio of total DOTATATE:total 64Cu of about 125:1 to about 1:1 and is a single-dose vial containing 148 MBq (4 mCi) of 64Cu-DOTATATE at calibration date and time in a 4 mL solution volume, wherein the radiochemical purity of the drug product is ≥96%.
Dependencies are inferred from the claim text.