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          Production of Zirconium-89 and the Development of Zr-89 Radiopharmaceuticals

          Closed for proposals

          Project Type

          Coordinated Research Project

          Project Code

          F22071

          CRP

          2223

          Approved Date

          4 December 2018

          Status

          Active - Ongoing

          Start Date

          3 December 2019

          Expected End Date

          31 December 2024

          Participating Countries

          Canada
          China
          France
          Germany
          India
          Iran (Islamic Republic of)
          Italy
          Japan
          Poland
          Portugal
          Republic of Korea
          Romania
          Saudi Arabia
          South Africa
          United Kingdom of Great Britain and Northern Ireland
          United States of America

          Description

          Positron Emission Tomography (PET) technique is an exciting tool in nuclear medicine capable of imaging biological processes up to subcellular concentrations at molecular level. Although the short half-life PET radiopharmaceuticals have been available for more than 3 decades, tracing and quantification of slow biological processes and molecules with longer biological half-lives have only been recently possible using PET tracers with longer half-lives including I-124 and Zr-89. Among those, Zr-89 has attracted higher value especially in the pharmacokinetics studies and clinical evaluation of monoclonal antibodies (mAbs) and large proteins due to attractive physicochemical properties. This Coordinated Research Project (CRP) will identify new technical aspects of the targetry, production and quality control of Zr-89 radioisotope and related radiopharmaceuticals with slow pharmacokinetics especially mAbs.

          Objectives

          Formulate guidelines to enhance and strengthen the expertise and capability of Member States in production (targetry, separation) and quality control of Zr-89 radioisotope as well as covering all aspects of Zr-89 radiopharmaceuticals development.

          Specific objectives

          Producing guidelines for the production of Zr-89 radioisotope using medical cyclotrons through the 89Y(p,n)89Zr and the optimization of:
          -Available targetry methods (solid and liquid targets)
          -Available separation purification methods
          -Quality control protocols of radioisotope produced

          Producing guidelines for preparation, evaluation and quality control of Zr-89 labelled molecules with focus on developing Zr-89 radiopharmaceuticals including:
          -Biomolecule conjugation
          -Radiolabeling characterization, Stability studies
          Quality control
          In-vitro specificity evaluation (such as Immunoreactivity, receptor binding, cell kinetic studies etc.)
          -Preclinical studies in laboratory animal models -etc.

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