On July 24, 2023 ARTBIO, Inc. (ARTBIO), a clinical-stage radiopharmaceutical company developing a new class of targeted alpha radioligand therapies (ART), and SpectronRx, a leading radiopharmaceutical developer and manufacturer, reported a global strategic partnership agreement to support manufacturing of components of ARTBIO’s AlphaDirectTM isotope isolation technology (Press release, ARTBIO, JUL 24, 2023, View Source [SID1234637912]).
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As part of the agreement, SpectronRx will be responsible for manufacturing a critical component of ARTBIO’s proprietary AlphaDirectTM technology. AlphaDirectTM is a first-of-its-kind system that delivers highly pure Pb212 from widely available raw materials. The multi-year agreement covers an initial technology transfer and development phase, followed by qualification and release of the technical components.
"We have a long history in managing complicated technology projects involving radioactive materials," said SpectronRx co-founder and CEO John Zehner. "We understand the importance of collaboration for companies developing new technologies aimed at creating radioligand therapies. SpectronRx is well-equipped and proud to partner with ARTBIO to develop and supply key components of AlphaDirectTM."
ARTBIO pioneered the AlphaDirectTM technology to create an optimized and proprietary Pb212 isotope isolation technology with unique advantages, including:
Benchtop format, which can be operated in facilities of any size.
Simple process with no fluid separation that results in 99.9%+ purity.
Streamlined supply chain with starting materials derived from accessible nuclear industry stockpiles that minimize uncertainty and cost.
SpectronRx will tap into its expertise for handling and producing rare medical radioisotopes such as Ac-225 (actinium-225) and Pb-212, along with its infrastructure for Radiopharmaceutical Contract Development (rCDMO) and Radiopharmaceutical Contract Manufacturing (rCMO). This unique combination and its extensive regulatory track record will enable ARTBIO to effectively improve and validate its manufacturing processes to get them ready for FDA and EMA review.
"We are pleased to partner with SpectronRx, a company with extensive experience and capabilities in managing nuclear chemistry projects," said Emanuele Ostuni, Ph.D., Chief Executive Officer of ARTBIO. "Handling high doses of radioactivity is an extremely complex process, and it was critical that we work with a partner that understands the specific requirements needed and can create a customized solution for our proprietary AlphaDirectTM technology. With SpectronRx’s expertise, we are a step closer to the establishment of the ARTBIO manufacturing network."
"ARTBIO’s technology has the potential to revolutionize the field of cancer treatment," added SpectronRx President Anwer Rizvi. "We are thrilled to be a part of their incredible journey."