A good nuclear infrastructure is necessary to produce radiopharmaceuticals. The guarantee for safe production and the handling of radioactive materials relies on it. To ensure that the nuclear materials are safe for patients, FIELD-LAB uses facilities and processes that are in line with Good Manufacturing Practice (GMP) standards. These type of facilities are complex, rare and expensive.
As partner within the FIELD-LAB consortium NRG realises the needed nuclear infrastructure, covering the complete route of nuclear medicine product development. From nuclear material generation, to radiological laboratories for pre-clinical research, to small scale GMP radiopharmaceutical production for clinical trials.
On this page, we will elaborate on the infrastructure available for the research, processing, production and distribution of medical isotopes.
NRG is a supplier and leading partner within FIELD-LAB. AND operator of the High Flux Reactor (HFR) on the site in Petten. Most of the medical isotopes used worldwide are currently produced in the HFR.
Our nuclear infrastructure is available to partners in FIELD-LAB for research, development, production and distribution of medical isotopes. Which facilities do we offer?
Sander de Groot
Sr. Program Manager Medical Isotope Development
The HFR supplies the isotopes to FIELD-LAB and all nuclear infrastructure available to FIELD-LAB is located close to the reactor in Petten. This secures the reliable supply of essential radioactive materials to FIELD-LAB, with minimised transport losses and logistic complexity.
In addition to this, with its available power, the reactor provides upscaling opportunities whenever this is needed during the R&D project and as soon as the new nuclear therapy hits the market.
With the new Pallas reactor expected in the near future, the isotope production in Petten will be ensured on a long term basis.
The High Flux Reactor has been operational since 1961 and proves its value continuously with supply to treat 30.000 patients worldwide on a daily basis. Globally, the HFR is the largest supplier of medical isotopes at present.
With the progress of the new PALLAS reactor, the long term continuity of this important asset will be guaranteed.
FIELD-LAB includes a GMP facility for small-scale production of nuclear medicine for clinical research. GMP stands for “Good Manufacturing Practice”, a set of regulations and guidelines that need to be followed to meet the highest quality standards and secure the materials produced are safe for use in patients.
A hot cell is a working space surrounded by radiation shielding to allow researchers to handle radioactive materials safely.
The GMP facility has four hot cell lines: two pairs, for the preparation, subsequent purification and production of medical products. All based on handling beta- and alpha-emitting isotopes.
The hot cell environment and internals generally comply to GMP C standards. For the aseptic preparation or synthesis of radiopharmaceutical products, a GMP A standard hot cell is available for both alpha- and beta-emitter materials.
Radiological laboratories are available to FIELD-LAB for non-GMP R&D activities.
A new radiological laboratory such as the Jaap Goedkoop Laboratory in Petten can handle small amounts of radioactive material, and can be used for production process development and small scale production for R&D tests and pre-clinical research.
Similar activities can take place in the dedicated alpha-laboratory, also available to FIELD-LAB, allowing the handling and production of alpha-emitter materials.
The Petten site is a world-renowned medical isotope and nuclear technology hub. In line with the Dutch regulations, all nuclear waste produced or handled in Petten and requiring long term storage, is responsibly contained and transported to the Dutch central location for nuclear waste.
The logistics of FIELD-LAB is a result of decades of experience. We are familiar with the whole logistic chain of nuclear material transport. For materials that lose their activity quickly over time, it is important to have a lean and robust logistical system.