Innovations in Radioisotope Synthesis Building Blocks
"As the Chemical Safety Operations manager at Fera, I am particularly interested by the complexities and risks associated with securing a stable supply chain of isotopically labelled substances on behalf of our clients."
Environmental fate studies are a fundamental part of chemical risk assessment, but there are subtle
differences between how different agencies assess safety. The REACH regulations of the European
Chemical Agency (ECHA) take a more conservative approach to non-extractable residues compared to
other agencies.
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Overcoming Challenges in the Supply Chain
Radioisotopes play a crucial role in our understanding of the intricate pathways of metabolism and degradation of substances within our environment. Producers and manufactures of chemical substances that enter the environment are obligated to assess the rate and route of dissipation of their product as part of the risk assessment and regulatory approval process. The most robust way to do this is to use a radiolabelled version of their active ingredient. As the Chemical Safety Operations manager at Fera, I am particularly interested by the complexities and risks associated with securing a stable supply chain of isotopically labelled substances on behalf of our clients. Delays during risk assessment project programmes can impact market approval timelines, negatively impacting sales and revenue generation for our customers. In this article, we delve into the challenges of sourcing building blocks for radioisotope synthesis, with a focus on Carbon-14 (C14).
The Historical Carbon-14 Supply Landscape
Traditionally, Carbon-14 has been a cornerstone isotope during the synthesis of isotopically labelled compounds. Its favourable characteristics, including a lower decay energy and a prolonged half-life, make it the ideal candidate for incorporation into organic molecules. Until 2009, the global supply of Carbon-14 primarily relied on two key sources: the Chalk River reactor in Canada and the Mayak site in Russia.
Since 2009, The Mayak site, in particular, dominates the global supply of enriched Carbon-14. The supply of radioactive material from the Mayak reactor to processing laboratories takes the form of stable barium [14]-carbonate salt (Ba14CO3) as a precursor. From this salt, 14CO2 is evolved and utilised in the creation of various aromatic or aliphatic building blocks within a bespoke radiochemical synthesis pathway.
Understanding the Supply Chain
Despite its historical prominence, recent disruptions to the supply chain and a subsequent desire to identify alternatives to the Mayak source there has been a re-evaluation of Carbon-14 sourcing and enrichment. This has led to the emergence of CCNuclear within the market, a company with a history of working within the nuclear industry and entering the radioisotope supply market with a fresh approach.
CCNuclear adopts an innovative approach, harvesting nuclear residue containing Carbon-14 from CANDU pressurised heavy-water reactors from around the globe. This nuclear residue serves as the raw material for RC-14, a new company based in South Africa. RC-14 specialises in enriching Carbon-14 from the nuclear residue supplied by CCNuclear thus reducing the over reliance on one source. This process not only ensures a consistent supply of enriched Carbon-14 but also diversifies the supply, contributing to the resilience and sustainability of the global radioisotope supply chain.
A Potential New Era in Radioisotope Synthesis
The entry of CCNuclear and RC-14 into the radioisotope supply market marks a paradigm shift in the industry and supply. This collaborative effort and specialised enrichment exemplify the resilience and adaptability of the scientific community.
The development of a new, innovative process for Carbon-14 synthesis not only addresses past challenges but also opens avenues for the preservation and expansion of the supply of radioisotopes.
This stability in the supply chain is particularly crucial for laboratories such as Fera as it enables us to continue to support our clients by enabling quality and insightfulness of chemical safety studies within the realms of metabolism and environmental fate disciplines.
Fera Science conduct various environmental fate and metabolism studies for customers operating within agrochemical, veterinary medicine, human pharmaceutical, and general chemicals (REACH).