New Tracer Development

The NEPTIS® control system provides an open flexible platform for implementing new radiotracers for reliable and reproducible manufacturing.

At ORA, we provide technical and regulatory expertise and support for the development, implementation and testing of new tracers on NEPTIS® automated synthesizers. In collaboration with specialized partners for the development of non-proprietary disposable cassette and reagent kits, we can ensure that your new tracer project is effectively moving forward. ORA has an impressive track record for collaboration with various research and industrial partners for the development of new tracers from the clinical trials stage to commercial production.

Research Lab in Lyon

Located in the CERMEP building in Lyon, our research laboratory is equipped with 5 research hot cells, quality control devices and offices. It offers full time access to a Cyclone 18/9 for radioactivity production. Our team is intimately involved in multiple collaborations with pharmaceutical companies and universities. This place is only dedicated to research and therefore our chemists can dedicate 100% of their time to the following services:

  • Existing synthesis optimization
  • Testing of labelling conditions with increased amounts of starting radioactivity
  • Process review with implementation of the latest chemistry techniques
  • Cassette design, testing and documentation
  • Drafting and testing of standard operating procedures (SOP)
  • And more …

University Collaborations

Over the years, ORA has been involved in numerous collaborations with universities (Europe and USA). Different aspects of research covered in these projects:

  • Installation and testing of beta synthesizer before marketing
  • Development of new labelling method
  • Supply of NEPTIS® synthesizers to support PhD thesis
  • Proposal of new research subject for PhD students, long term collaborations
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Isotopes

The sale of synthesizer requests sometimes specify development of accessories as well as new innovative chemistries. ORA has several ongoing projects for various isotopes:

  • Labelling of small molecules, antibody, nanobody and complexes with 68Ga, 177Lu, 131I, 188Re, 90Y, 89Zr, 211At, 225Ac, 99mTc.

Radiopharma consulting

The commercial production of [18F]PET tracers started in the 90’s, with the [18F]FDG, moving from Universities laboratories to GMP facilities fully dedicated to that specific production. At that time, came major modifications of the GMP regulation for the production of radiopharmaceutical and new monographies in the pharmacopeia.

From single isolated laboratories, it moved to a global network supplying more and more hospitals.

Most laboratory were mono product, the irreplaceable [18F]FDG, and slowly moved to the production of other tracers like [18F]FLT, [18F]F-Choline, [18F]NaF…

For that time frame, current employees at ORA accomplished the design of facilities, drafted marketing authorizations, developed QMS ensuring full compliance for GMP inspections, training of production team, process optimization, synthesizers maintenance for Ion Beam Applications (IBA®), Advanced Accelerator Applications (AAA), PETNET®, Moltek, BIONT, KUL, UZA…

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Recent involvements

In 2009, the NEPTIS® project was started based on the long experience in radiotracers production in GMP environment and became the combination of a multi-purpose PET synthesizer and an advanced software system meeting the latest GMP requirements.

This new combination offered then the capability of creating an unlimited number of individualized radiotracer synthesis applications.

Gradually, NEPTIS® synthesizers were approved worldwide by many drug agencies. NEPTIS® was the first synthesizer to receive the US, European and Japanese approval for a proprietary tracer used in the Alzheimer disease detection (Amyvid, Florbetapir).

In order to increase customer confidence and to meet the strictest regulations, ORA has developed and implemented a Quality Management System which documents the company’s best business practices, better satisfies the requirements and expectations of its customers and improves the overall management of the company.

This Quality Management System of ORA, meets today the requirements of the international standard ISO 13485:2016. This system addresses the design, development, production, installation and servicing of the company’s products.

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Available

With almost 25 years of collaboration with major pharmaceutical companies, ORA permanently updates his regulatory database, and permanently adapts its QMS. Today, at ORA, we are able to support any new development of radiopharmaceuticals (diagnostic and therapy) for:

  • Chemistry
  • QC development
  • Documentation
  • Automation
  • Process optimization
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Our Company Quality Policy

ORA consistently provides products and services that meet or exceed the requirements and expectations of its customers. It will actively pursue ever-improving quality through programs that enable each employee to do their job right the first time and every time.

It commits to provide a quality management system in line with ISO 13485 requirements and with the MHLW Ministerial Ordinance N°169 (Japanese regulatory requirements).

Click to download our ISO 13485 certificate