During EANM 2017, ORA™ is launching NEPTIS® xSeed™, a versatile kitless synthesizer for accelerating the development of new tracers and their seamless transfer to GMP production.

Philippeville, Belgium, October 21th 2017 / Optimized Radiochemical Applications (ORA™) today announced the effective launch and availability early 2018 of its new NEPTIS® xSeed™ kitless synthesizer, a versatile synthesizer for the development of new tracers and their seamless transfer to GMP production.

Tracer production is increasingly evolving towards the use of automated synthesis modules with a disposable cassette/kit system for production of clinical radiopharmaceuticals. Such a move comes with many advantages (automation, multi-Curie handling, regulatory compliance, improved radiation safety). But the use of such synthesis modules also presents radiochemists with the challenge of needing to reconfigure for production of new radiotracers that are still at research level, whilst maintaining full automation. In particular the production costs and availability of kits may limit the viability of such research.

Current commercially available kitless automated synthesis modules are only partially addressing that challenge. Indeed, module reconfiguration raises the issue of how best to clean and dry the module between syntheses. Moreover, sequence configurations developed on these types of modules are not directly transportable to modules with disposable kits, creating additional complications, delays and costs when moving from pure research to clinical trials, and then again into commercial production.

The NEPTIS® xSeed™ automated kitless module aims to overcome all these inconveniences. NEPTIS® xSeed™ comes with a similar fixed valve arrangement to existing NEPTIS® modules (which use disposable cassettes), built-in HPLC purification, and SPE reformulation capability. NEPTIS® xSeed™ also features an automatic washing system after completion of a synthesis to clean, disinfect, wash and/or dry all the fluid lines and reaction chamber, preparing the machine for immediate production of a new and/or different synthesis, with batch-to-batch reproducibility and the guaranteed elimination of any possible contamination between runs. Since it is using the same NEPTIS® Control software, any synthesis sequence developed on NEPTIS xSeed™ is directly transferable to NEPTIS® production modules using disposable cassettes, simplifying the transition from research to GMP production, while eliminating the unnecessary costs of procuring cassettes/kits at the research stage.

With NEPTIS® xSeed™ module, ORA aims to simplify the work of the radiochemistry researchers around the world and provide a faster and more economical track to new radiopharmaceutical drug development.

NEPTIS xSeed

NEPTIS xSeed and its washing system

 

NEPTIS® xSeed™ is delivered with NEPTIS® Designer and NEPTIS® Trending application software.

 

NEPTIS® Designer allows the development of customized syntheses for immediate operation with any NEPTIS® synthesizer.

NEPTIS® Trending provides traceability and analysis/comparison of all development and testing data, an invaluable tool for the researcher.

 

 

 

ORA™ is exhibiting its new NEPTIS® xSeed™ module at booth number #211 Hall X2 at the European Society of Nuclear Medicine annual meeting from 22 to 24 October 2017 in Vienna, Austria.

About NEPTIS®
NEPTIS® synthesizers, dedicated for the production of PET radiopharmaceuticals, aimed since their inceptions to address the various challenges, different by nature, of personalized medicine, a young but rapidly advancing field of healthcare: restoring freedom for researchers with an open and flexible freedom, providing developers with a robust tool from clinical trials to commercial production, and offering producers a guarantee or reliable and repetitive performance. Additional information about NEPTIS® is available at www.neptis-vsa.com.

About Optimized Radiochemical Applications (ORA™)
ORA, an innovation-driven Belgian company based founded in 2006, is developing an extensive range of PET synthesizers for existing and new radiopharmaceuticals and collaborates with major research institutions and pharmaceutical companies worldwide. Additional information about ORA is available at www.oradiochem.eu.

©ORA Belgium, 2017. All rights reserved. PR17016
NEPTIS® is a trademark of ORA™

For immediate release

Contact: Vincent Tadino
Phone: (0032) 71 61 40 53
Email: info@oradiochem.eu