Abstract
The IAEA activities on supporting development of therapeutic radiopharmaceuticals are focused on identified radionuclides that can be produced in large quantities and making use of carrier molecules which can be synthesized locally or procured from commercial sources or already available in MS from other related programs. The main emphasis is on {sup 90}Y and {sup 177}Lu based products, which cover the hard beta energy and soft beta energy range respectively, and also since both these radionuclides can be produced in large quantities with very high specific activity and high radionuclidic purity. The services to MS are provided through implementing Coordinated Research Projects (CRP), Technical Cooperation (TC) projects, technical meetings and regional training courses in addition to documenting practically useful technical information related to these products though IAEA publications. The CRP is a group activity in which nearly 15 participants from as many countries come together to work towards an identified objective. Two of the completed CRPs in this area are: (i) Comparative evaluation of therapeutic radiopharmaceuticals (2002-2005) that focussed on the development of 'in vitro' and 'in vivo' techniques for evaluating new generation therapeutic radiopharmaceuticals; and (ii) Development of generator technologies for therapeutic radionuclides (2004-2007) that addressed technologies for {sup
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Pillai, M R.A.;
Haji-Saeid, M;
Zaknun, J;
Ramamoorthy, N
[1]
- Department of Nuclear Sciences and Applications, International Atomic Energy Agency, Vienna (Austria)
Citation Formats
Pillai, M R.A., Haji-Saeid, M, Zaknun, J, and Ramamoorthy, N.
The IAEA Activities on Supporting Development of Therapeutic Radiopharmaceuticals and Capacity Building in Member States.
IAEA: N. p.,
2009.
Web.
Pillai, M R.A., Haji-Saeid, M, Zaknun, J, & Ramamoorthy, N.
The IAEA Activities on Supporting Development of Therapeutic Radiopharmaceuticals and Capacity Building in Member States.
IAEA.
Pillai, M R.A., Haji-Saeid, M, Zaknun, J, and Ramamoorthy, N.
2009.
"The IAEA Activities on Supporting Development of Therapeutic Radiopharmaceuticals and Capacity Building in Member States."
IAEA.
@misc{etde_21525750,
title = {The IAEA Activities on Supporting Development of Therapeutic Radiopharmaceuticals and Capacity Building in Member States}
author = {Pillai, M R.A., Haji-Saeid, M, Zaknun, J, and Ramamoorthy, N}
abstractNote = {The IAEA activities on supporting development of therapeutic radiopharmaceuticals are focused on identified radionuclides that can be produced in large quantities and making use of carrier molecules which can be synthesized locally or procured from commercial sources or already available in MS from other related programs. The main emphasis is on {sup 90}Y and {sup 177}Lu based products, which cover the hard beta energy and soft beta energy range respectively, and also since both these radionuclides can be produced in large quantities with very high specific activity and high radionuclidic purity. The services to MS are provided through implementing Coordinated Research Projects (CRP), Technical Cooperation (TC) projects, technical meetings and regional training courses in addition to documenting practically useful technical information related to these products though IAEA publications. The CRP is a group activity in which nearly 15 participants from as many countries come together to work towards an identified objective. Two of the completed CRPs in this area are: (i) Comparative evaluation of therapeutic radiopharmaceuticals (2002-2005) that focussed on the development of 'in vitro' and 'in vivo' techniques for evaluating new generation therapeutic radiopharmaceuticals; and (ii) Development of generator technologies for therapeutic radionuclides (2004-2007) that addressed technologies for {sup 90}Sr/{sup 90}Y and {sup 188}W/{sup 188}Re generators and which can be easily adapted by MS. The participants in the CRP on 'Comparative evaluation of therapeutic radiopharmaceuticals' used the somatostatin analogue, DOTATATE as the lead molecule for developing radiopharmaceuticals and testing the efficacy by in vitro biological assays and animal biodistribution studies. A significant outcome of the CRP was that {sup 177}Lu-DOTATATE therapy is now practised in several of the CRP participating countries including Brazil, India, Italy, and Poland. The major outcome of the CRP on 'Development of generator technologies for therapeutic radionulclides' is the development of a novel technology generator for {sup 90}Sr/{sup 90}Y, an electrochemical generator system (named by the developers as 'Kamadhenu', a mythological Indian cow that provides perennial milk supply) for the preparation of {sup 90}Y of high purity for therapy. The further development of the system into an automated module has been done by a collaborating commercial entity, Isotope Technologies Dresden (ITD), Germany, and the prototype module will be installed shortly in Cuba under an IAEA technical cooperation project. The development of 'extraction paper chromatography (EPC)' for estimation of ppm levels of {sup 90}Sr in {sup 90}Y is another significant achievement under the same CRP. EPC is a novel analytical technique with potential for application in other fields. All such research outputs of the CRP are published as IAEA documents and can be freely downloaded. Currently there are two other ongoing CRPs: (i) Development of {sup 177}Lu radiopharmaceuticals for radionuclide therapy (2006-2009) and (ii) Development of therapeutic radiopharmaceuticals using {sup 90}Y and {sup 188}Re (2008-2011). Thirty one research groups from across the world are participating in these CRPs, which are investigating the development of therapeutic radiopharmaceuticals for bone pain palliation, solid tumours including hepatocarcinoma as well as agents for radiosynoviorthesis. Major outcomes of the CRP on {sup 177}Lu are the commencement of the production of {sup 177}Lu in over a dozen reactors in the participating countries and translation of {sup 177}Lu-EDTMP into a cost effective therapeutic radiopharmaceutical, following extensive pre-clinical evaluation studies, and through a joint CRP with the IAEA Nuclear Medicine Section that is focussing on the multicentric Phase I/II clinical trial of {sup 177}Lu-EDTMP in metastatic prostate and breast cancer. The IAEA supports currently 14 technical cooperation projects in MS dealing with implementation of therapeutic radiopharmaceuticals including therapeutic radionuclide generators. Recently, the IAEA conducted a regional training course on 'Therapeutic radiopharmaceuticals, production, QA/QC and implementation of GMP' under a regional project in the Asia-Pacific region in which 25 participants form 17 MS participated. (author)}
place = {IAEA}
year = {2009}
month = {Jul}
}
title = {The IAEA Activities on Supporting Development of Therapeutic Radiopharmaceuticals and Capacity Building in Member States}
author = {Pillai, M R.A., Haji-Saeid, M, Zaknun, J, and Ramamoorthy, N}
abstractNote = {The IAEA activities on supporting development of therapeutic radiopharmaceuticals are focused on identified radionuclides that can be produced in large quantities and making use of carrier molecules which can be synthesized locally or procured from commercial sources or already available in MS from other related programs. The main emphasis is on {sup 90}Y and {sup 177}Lu based products, which cover the hard beta energy and soft beta energy range respectively, and also since both these radionuclides can be produced in large quantities with very high specific activity and high radionuclidic purity. The services to MS are provided through implementing Coordinated Research Projects (CRP), Technical Cooperation (TC) projects, technical meetings and regional training courses in addition to documenting practically useful technical information related to these products though IAEA publications. The CRP is a group activity in which nearly 15 participants from as many countries come together to work towards an identified objective. Two of the completed CRPs in this area are: (i) Comparative evaluation of therapeutic radiopharmaceuticals (2002-2005) that focussed on the development of 'in vitro' and 'in vivo' techniques for evaluating new generation therapeutic radiopharmaceuticals; and (ii) Development of generator technologies for therapeutic radionuclides (2004-2007) that addressed technologies for {sup 90}Sr/{sup 90}Y and {sup 188}W/{sup 188}Re generators and which can be easily adapted by MS. The participants in the CRP on 'Comparative evaluation of therapeutic radiopharmaceuticals' used the somatostatin analogue, DOTATATE as the lead molecule for developing radiopharmaceuticals and testing the efficacy by in vitro biological assays and animal biodistribution studies. A significant outcome of the CRP was that {sup 177}Lu-DOTATATE therapy is now practised in several of the CRP participating countries including Brazil, India, Italy, and Poland. The major outcome of the CRP on 'Development of generator technologies for therapeutic radionulclides' is the development of a novel technology generator for {sup 90}Sr/{sup 90}Y, an electrochemical generator system (named by the developers as 'Kamadhenu', a mythological Indian cow that provides perennial milk supply) for the preparation of {sup 90}Y of high purity for therapy. The further development of the system into an automated module has been done by a collaborating commercial entity, Isotope Technologies Dresden (ITD), Germany, and the prototype module will be installed shortly in Cuba under an IAEA technical cooperation project. The development of 'extraction paper chromatography (EPC)' for estimation of ppm levels of {sup 90}Sr in {sup 90}Y is another significant achievement under the same CRP. EPC is a novel analytical technique with potential for application in other fields. All such research outputs of the CRP are published as IAEA documents and can be freely downloaded. Currently there are two other ongoing CRPs: (i) Development of {sup 177}Lu radiopharmaceuticals for radionuclide therapy (2006-2009) and (ii) Development of therapeutic radiopharmaceuticals using {sup 90}Y and {sup 188}Re (2008-2011). Thirty one research groups from across the world are participating in these CRPs, which are investigating the development of therapeutic radiopharmaceuticals for bone pain palliation, solid tumours including hepatocarcinoma as well as agents for radiosynoviorthesis. Major outcomes of the CRP on {sup 177}Lu are the commencement of the production of {sup 177}Lu in over a dozen reactors in the participating countries and translation of {sup 177}Lu-EDTMP into a cost effective therapeutic radiopharmaceutical, following extensive pre-clinical evaluation studies, and through a joint CRP with the IAEA Nuclear Medicine Section that is focussing on the multicentric Phase I/II clinical trial of {sup 177}Lu-EDTMP in metastatic prostate and breast cancer. The IAEA supports currently 14 technical cooperation projects in MS dealing with implementation of therapeutic radiopharmaceuticals including therapeutic radionuclide generators. Recently, the IAEA conducted a regional training course on 'Therapeutic radiopharmaceuticals, production, QA/QC and implementation of GMP' under a regional project in the Asia-Pacific region in which 25 participants form 17 MS participated. (author)}
place = {IAEA}
year = {2009}
month = {Jul}
}