Indiana-based radiopharmaceutical contract development and manufacturing organization producing Ac-225 at a scale
SpectronRx, a leading radiopharmaceutical contract development and manufacturing organization (CDMO/CMO) and isotope producer, today announced it has commenced mass production of high-purity Actinium-225 (Ac-225). Using a proprietary accelerator-based method, SpectronRx is now producing this critical medical isotope at a commercial scale sufficient to meet rising global demand for targeted radiopharmaceutical therapies.
SpectronRx’s innovative production method overcomes longstanding
challenges associated with the limited availability of Ac-225, which has been a
major bottleneck for advancing life-saving drugs. By addressing this shortfall,
SpectronRx is enabling drug developers, manufacturers and researchers worldwide
to access a reliable, abundant supply of Ac-225 for medical use.
“This
marks a significant milestone for our company, our clients and the
patients who will benefit from the advancements in Actinium-225-labeled drug
products,” said John Zehner, CEO of SpectronRx. “With the expanding pipeline of
Ac-225-based radiopharmaceuticals making progress toward FDA approval, there's
promising evidence that the prognosis for certain cancers and other diseases
could substantially improve. However, consequently, this has increased demand
for Ac-225-labeled drugs, leading to notable shortages. But now we can meet
that demand, which is what makes this development so exciting for the
future of patient care.”
SpectronRx
now owns multiple accelerators that can
produce Ac-225 and plans to add more as it continues to scale its operations to meet global
demand. SpectronRx
has made an essential advancement in de-risking the Ac-225 supply chain.
“Our team has successfully scaled a robust process for
manufacturing high-purity Ac-225, and we are ready to supply the market,” said
Anwer Rizvi, President of SpectronRx. “We have established the quality systems
and manufacturing capacity to support our partners from early-phase clinical
trials through to commercial launch. This milestone reinforces our commitment
to leadership in radiopharmaceuticals and our confidence in the profound
clinical potential of Actinium-225 as a powerful tool against cancer.”
Ac-225 is a highly sought-after alpha-emitting isotope. When
attached to a targeting molecule, it can be delivered directly to cancer sites,
where it destroys tumor cells with minimal damage to surrounding healthy tissue
and has the potential to inhibit replication. Until now, the scarcity of Ac-225
has been a significant barrier to its widespread use in medicine. SpectronRx’s
production capability directly resolves this historical challenge.
SpectronRx boasts an impressive footprint with over 250,000
square feet of CDMO space, more than 50 state-of-the-art hot cells and clean
rooms and a dedicated team of 220 employees across five locations in the US and
Europe. As a global leader in radiolabeling and supply, SpectronRx manufactures
and delivers Ac-225 radiolabeled drug products across 29 countries.
Collaborating with more than 31 pharmaceutical and biotech companies,
SpectronRx’s highly skilled radiopharmaceutical experts are at the forefront of
developing and producing life-saving nuclear medicines.
To
learn more, visit SpectronRx.com.