Speaker
Dr
Mark Harfensteller
(ITG Isotope Technologies Garching, Germany)
Description
The 68Ge/68Ga radionuclide generator (68Ge, T1/2 = 270.95 d) is an excellent cyclotron-independent source for the positron emitter 68Ga which is successfully used in clinical PET. Nevertheless there remain open problems in the routine use related to the applicability of the technique in clinical environment and legal aspects.
An effective application of the generator produced 68Ga can be limited by poor chemical and pharmaceutical quality of the generator eluate. Thus traces of metals, as a consequence of the use of metal oxide based matrixes; rather large volume and high acidity lead to suboptimal conditions of the radiolabelling reaction and can decrease the reproducibility in the routine preparation of 68Ga-radiopharmaceuticals. In order to extend the shelf-life of the generator systems, high initial activities of the 68Ge are used. A long-term utilization of the generator systems in non-gmp environment can cause, however, decreasing of pharmaceutical quality and conflict with legal aspects of in-house radiopharmaceutical production. Finally, users face the problem of the generator utilization, since long-lived 68Ge can not be declared as decay waste.
In this context we propose a novel “metal free” 68Ge/68Ga radionuclide generator system dedicated for production of high quality gmp grade 68Ga preparations. The concept includes an effective 68Ge management and improved logistic for the routine utilization of the radionuclide generator system in clinical environment.
Last Name
Harfensteller
First Name(s)
Mark
Institution
Isotope Technologies Garching
Please submit a short bio (max 1500 characters)
Dr.-Ing. Mark Harfensteller studied Mechanical Engineering at the Technische Universitaet Muenchen. He specialized in the field of production technology where he joined Prof. Zaeh and Prof. Reinhart at the institute of machine tools and industrial management (iwb) from 2002 to 2006. Besides production development in mechatronic and chemical engineering he focused in the development of production technology of the alpha-emitter Actinium-225 by the proton irradiation of Radium-226.
Mark accompanied the successful Ac-225 project until 2008 where he joined ITG isotope technologies Garching as head of production.
Address
Lichtenbergstr. 1
Telephone
+49 89 28913923
E-mail address
mark.harfensteller@itg-garchin
Author
Dr
Mark Harfensteller
(ITG Isotope Technologies Garching, Germany)
Co-authors
Prof.
Andreas Türler
(Paul Scherrer Institut, Villigen)
Dr
Josue Moreno
(ITG Isotope Technologies Garching, Germany)
Dr
Konstantin Zhernosekov
(Paul Scherrer Institut, Villigen)
Oliver Buck
(ITM Isotope Technologies Munich, Garching)
Oliver Leib
(ITG Isotope Technologies Garching, Germany)
Dr
Richard Henkelmann
(ITG Isotope Technologies Garching, Germany)
Dr
Tuomo Nikula
(ITM Isotope Technologies Munich, Garching)
