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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