Nucléaire medical

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Nucléaire medical

Message par energy_isere » 20 oct. 2019, 10:46

Le projet SHINE de fabrication d'isotopes Mo99 radioactif pour traitement médical, reçoit sa licence.
Mise en service commercial en 2022. Aux USA.
US regulator accepts SHINE's radioisotope operating licence application

16 October 2019

The US Nuclear Regulatory Commission (NRC) has accepted SHINE Medical Technologies' operating licence application for its medical isotope production facility in Janesville, Wisconsin. SHINE said the NRC's acceptance confirms that its application was "complete and of sufficient quality" for the NRC to start its detailed technical review of the application.

SHINE's application seeks regulatory approval to operate its transformational non-reactor technology that will produce medical isotopes, including molybdenum-99 (Mo-99), which the company says is used in more than 40 million medical procedures every year. The facility will be capable of supplying two-thirds of US patient demand for the isotope. SHINE expects to begin production of Mo-99 in 2021, with commercial production starting in 2022.

"The NRC's review of our operating license application is another step forward for SHINE’s effort to commercialize the Mo-99 isotope through our first-of-its-kind medical isotope production facility," said Greg Piefer, SHINE's founder and CEO.

Jim Costedio, SHINE's vice president of regulatory affairs and quality, added that development of the operating license application had logged more than 150,000 person-hours of work.

SHINE, which broke ground on construction in May, said ongoing excavation at the site of the facility began in September. The next step in the construction process, concrete work, is expected to start this month.

The next step involves the NRC conducting a regulatory audit to determine a detailed schedule for the remainder of the review.
http://www.world-nuclear-news.org/Artic ... -operating

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Re: Nucléaire medical

Message par energy_isere » 30 oct. 2024, 00:19

Des médicaments radioactifs ? Une piste contre les cancers qui gagne de l'ampleur

AFP le 29 oct. 2024

Injecter dans l'organisme des composants radioactifs qui vont directement détruire les cellules cancéreuses. La piste n'a encore qu'une petite place dans l'arsenal des cancérologues, mais elle apparaît de plus en plus prometteuse et l'industrie pharmaceutique y investit désormais des milliards d'euros.

Un partenariat entre Sanofi et Orano.
..................................
lire https://www.connaissancedesenergies.org ... eur-241029

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Re: Nucléaire medical

Message par energy_isere » 16 nov. 2024, 11:29

Orano starts construction of thorium-228 facility

Friday, 15 November 2024

Orano subsidiary Orano Med has laid the foundations for its Advanced Thorium Extraction Facility plant in Bessines-sur-Gartempe in Haute-Vienne, western France. This facility is the world's first industrial plant dedicated to the production of thorium-228, a precursor of lead-212, for radioligand therapies.

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How the completed ATEF facility could look (Image: Orano)

Lead-212 targeted alpha therapy combines the ability of biological molecules to target cancer cells with the cell-killing potential of alpha emissions generated by lead-212. Orano Med says the development of these radiopharmaceuticals has long been hindered by the difficulty of producing them on an industrial scale.

Thanks to innovations that ensure a very high level of purity, the Advanced Thorium Extraction Facility's (ATEF) construction will industrialise the production process for thorium-228, under development for more than 10 years by the Laboratoire Maurice Tubiana (LMT). ATEF will supply all the ATLab (Alpha Therapy Laboratories) facilities set to manufacture lead-212-based drugs for patients worldwide.

The ATEF facility, scheduled for commissioning in 2027, will increase LMT's current production capacity tenfold. The project represents a total investment of about EUR250 million (USD264 million), creating nearly 70 direct and 100 indirect jobs. The ATEF project has been selected under the France 2030 plan following the call for "Industrialisation and health capacities 2030" projects and will receive public support of EUR22 million.

In the short-term, the combined production capacities of the ATEF and LMT will ensure supply for clinical trials and the commercial launches of Orano Med's first treatments. In ten years, this industrial platform will enable the production of 100,000 doses annually, the company said.

"Construction of the ATEF facility at our historic site in Bessines-sur-Gartempe is a significant step for growing our activities in the region," said Orano CEO Nicolas Maes. "The expansion of our production capacities in the radiopharmaceutical field also contributes to the industrial and economic revitalisation of our country. In addition, this project fulfills Orano's mission of maximising the value of nuclear materials, the core of our Group’s expertise."

Orano Med CEO Arnaud Lesegretain added: "We are convinced that radioligand therapies will soon become an essential tool in the fight against cancer. As the Phase II clinical trial of our most advanced drug, AlphaMedix, nears completion, we are building a globally unique integrated industrial platform to ensure the large-scale production and distribution of lead-212-based treatments."

Orano Med has lead-212 production facilities, laboratories and R&D centers in France and the USA.

In February this year, the company began construction of its Alpha Therapy Laboratory in Onnaing in northern France. This will be Europe's first industrial-scale pharmaceutical facility dedicated to the production of lead-212 based radioligand therapies. It will focus on the production of lead-212 therapies developed by Orano Med and their distribution in Europe. Orano Med is due to inaugurate a similar facility this year in Indianapolis to serve the US market.
https://www.world-nuclear-news.org/arti ... 8-facility

le communiqué de Orano en Français : https://www.orano.group/fr/actus/actual ... -plomb-212

la page de Orano sur l' Alphathérapie : https://www.orano.group/fr/decodage/lut ... -nucleaire

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