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01. The ICNAS experience
02. EANM 2014
SYNTHERA®
NEWSLETTER N° 7 - SPRING 2014
350 MODULES WORLDWIDE
IBA RadioPharma Solutions Synthera® Newsletter 7 - Spring 2014
03. Synthera® Users corner
03. Synthera® customer services
04. IBA radiochemistry team
With more than 350 modules sold worldwide, the Synthera® is the world reference of radiochemistry modules.
Read this newsletter and discover the latest developments performed on the Synthera®, IBA’s enhanced customer service, and the most recent market insight.
THE ICNAS EXPERIENCE
Synthera® has been providing reliable and efficient synthetic outcomes for a few years at ICNAS PET center (Instituto de Ciências Nucleares Aplicadas à Saúde of Coimbra, Portugal).
“ We have performed the validation
runs including stability test up to 10 hours of 18FMISO on IBA Synthera® platform (Synthera® & Synthera® HPLC). We have obtained high yields (25-30% ndc.) and quality control in accordance with the European Pharmacopoeia.
I was working with the SPE purification but the impurities profile of HPLC purification is way better. For centers like ours where the objective is the commercial distribution of FMISO, I have to ensure a long shelf-life and maximum injectable volumes (up to 10ml, for example)
” Antero AbrunhosaRadiochemistry Group Head at ICNAS
Coimbra Area, Portugal
2 | SYNTHERA® NEWSLETTER
IBA booth
If you had the opportunity to attend EANM in Lyon, you may have attended the didactic presentation in the IBA booth.
During this presentation, IBA presented the different phases of the establishing a PET center. Visitors also had the chance to perform a live synthesis on the worldwide reference in radiochemistry : Synthera®.
NEW: FMISO for hypoxia imaging and IFP™ R&D to support your research workThe conference attendees were able to see new set of consumables for FMISO on Synthera® platform and the IFP™ R&D cassette. IFP™ R&D is the IFP™ Nucleophilic that can be re-used for research purposes reducing your investment when developing new tracers on Synthera®. This new IFP™ will make you research much more affordable!
NEW radiopharmaceutical developments delighted the audience
We would like to acknowledge our dearest customers who dare to innovate and challenge Synthera® platform with their new developments. A particular thanks goes to the two presenters:
Dr. Antero Abrunhosa from ICNAS from Coimbra/Portugal for his passionate talk on their long list of commercial tracers on Synthera® platform including FDG, NaF, FMISO, FCH and [68Ga]-Ga-DOTANOC .
“ We have celebrated the 100th patient
injection in Jan 2014. We are very happy with the robustness/stability of our [68Ga]-Ga-DOTANOC on Synthera® platform. In this way, we can assure the large demand for this important tracer.
”Dr. Vicky Caveliers from l’UZ Brussel (Universitair Ziekenhuis) in Brussels/Belgium for her exciting talk on the routine tracers produced on Synthera® platform (FMISO, FET, FDG) and more specifically on the hot topic about Nanobodies. Dr. Vicky’s team is synthesizing [18F]-SFB - Nanobodies on Synthera® platform for their clinical trials in oncology and cardiology applications.
•
EANM 2013 : IBA NOTEWORTHY PRESENCE
Ayfer Soylu from Eczacıbası Monrol and Cristiana Gameiro, IBA product manager
FDOPA Nucleophilic pathway coming soon on Synthera® PlatformDuring the VIP entertainement event IBA was glad to announce 18FDOPA via Nucleophilic pathway to be developed on Synthera® platform. More details in the next issue.
One of our customers in Memphis/US is already producing, among other tracers FDA(6-[18F]-fluorodopamine) via a nucleophilic route on Synthera® platform in collaboration with Ground Fluor Pharmaceuticals, Inc.
We have been synthesizing 6-[18F]fluorodopamine (FDA) with the Synthera® platform for the past 6 months in sufficient yield and purity to allow routine production for human use. The aim of this study is to asses FDA as a potential alternative for mIBG imaging of neuroendocrine tumors.
”IBA award: the winners are…Congratulations to our IBA Scientific award winners:Mr Vítor Hugo Alves,ICNAS, Coimbra, Portugal for his innovative work presented during the ISRS 2013 in Korea with Ga-68-DOTANOC on Synthera®.
Mr. Vasko Kramer from PositronPharma, Chile who was represented by Dr. Horacio Amaral, who discussed some of the work done on Synthera® with PET tracers designed to image the dopaminergic system.
Read their full scientific paper at http://www.iba-radiopharmasolutions.com/media-center#scientific-publications
Dr. Antero Abrunhosa from ICNAS, Coimbra,PT Dr. Vicky Caveliers from VUB in Brussels, BE
Vítor Alves & Bruno scutnaire
(Courtesy: Piramal Imaging) NeuraCeq™ PET cases showing examples of negative florbetaben (18F) PET scan (top row)
and positive scan (bottom row).
Memphis team, USA
“
Mr. Vasko Kramer & Bruno Scutnaire
MARCH 2014 | 3
Synthera® V2 software update - More functionalities to help you with troubleshooting!
IBA is grateful to all customers who participated in the pilot tests for their precious feedback.
We will soon be giving more details to the community.
Synthera® V1 Corner- More flexibility for your team
Synthera® V1 software update trials are on-going on several customer sites around the world. Thank you to all customers who participated in the pilot tests for their precious feedback.
Coming-up next
We are real people, we like shaking hands. It would be great if we could talk over a cup of coffee during the next industry meetings:
OncoPET Apr 2-4, 2014 Groningen, Netherlands
ESRR Apr 24-27, 2014, Pamplona, Spain
TURKU Symposium May 24-27, 2014 Turku, finland
SNM Annual Meeting June 07-11, 2014, Saint Louis-Missouri/USA
15th WTTC, Aug 18-21, Prague/Czech republic
EU approval of NeuraCeq™ produced on Synthera® platform
Piramal Imaging recently announced that *NeuraCeq™ (florbetaben 18F) received marketing authorization from the European Commission.
NeuraCeq™ is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of beta-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment.
With this authorization, NeuraCeq™ will soon be available to provide valuable information that may give physicians more confidence in their clinical assessment and help them provide more personalized patient management as a negative scan may rule out AD as a cause of a patient’s cognitive decline.
*NeuraCeq™ (florbetaben 18F) is an investigational
PET amyloid imaging agent currently under review
by the U.S. Food and Drug Administration.
[18F]PR04.MZ, a new DAT imaging tracer
Positronpharma S.A from Chile in collaboration with Fundación Arturo Lopez Perez/Chile; CETRAM Universidad de Santiago/, the Pontifica Universidad Católica de Chile and the Institut für Kernchemie/Johannes Gutenberg-Universität in Germany has presented an outstanding lecture during the EANM 2013 entitled:
[18F]PR04.MZ for Quantification of Striatal and Extrastriatal Dopamine Transporters in Patients with Idiopathic Parkinson´s disease.
In his talk, Dr. Amaral from PositronPharma reported the reliable, high-yielding synthesis of [18F]-PR04.MZ, a new DAT imaging tracer, on the Synthera® Platform and the promising clinical results in demonstrating the potential for routine clinical applications.
USER’S CORNER
CUSTOMERSERVICES
PET/CT fusion image of striatal regions 120-135 min p.i., High tracer uptake in DAT-rich regions
and very low unspecific binding(Courtesy: Piramal Imaging) NeuraCeq™ PET cases showing examples of negative florbetaben (18F) PET scan (top row)
and positive scan (bottom row).
www.iba-synthera.com
IBA RADIOCHEMISTRY TEAM
Chemin du cyclotron, 3 1348 Louvain-la-Neuve Belgium
Tél. : +32 10 20 12 45 Fax : + 32 10 47 59 00 [email protected]
Neva Lazarova Functional Leader PET Radiochemistry [email protected]
Frederic Jodocy Sales Manager Europe, Middle-East & Africa [email protected]
Li ChenSales Manager [email protected]
Peter Leitner VP RadioPharma Solutions APAC [email protected]
Sylvain Savaria Sales Manager North America [email protected]
Chemistry team located in Fleurus/Belgium- ready to help you on time anythime
We would like to introduce you to our Chemistry team: chemists, PhD scientists, electromechanical and electronic engineers, software developer together to help you anytime and anywhere. This team of experts is located in Fleurus, Belgium. Their focus is not only on the new developments on the Synthera platform, but also on I-123 gas target and IBA Solid target and chemistry solutions for: I-123 I-124; Cu-64 & Zr-89 coming soon
More details on the chemistry of the non-standard radioisotopes in the next issue.
Next Issue
• Industrial meetings: ONCOPET, ESRR, Turku Symposium, SNM
• Other chemistry – Non-standard radioisotopes
• Technical newsletter for Synthera®
users• User’s corners• Synthera® V1 Corner• Next Synthera® user meeting
IBA RadioPharma Solu-tions
IBA RadioPharma Solutions
