The centrepiece of the agreement entails SpectronRx taking on the responsibility of manufacturing a vital component of ARTBIO's proprietary AlphaDirect system
ARTBIO partners with SpectronRx to produce key parts of ARTBIO's AlphaDirect technology. (Credit: Tumisu from Pixabay)
ARTBIO and SpectronRx have joined forces in a significant global strategic partnership to enhance the manufacturing process of components crucial to ARTBIO’s revolutionary AlphaDirect isotope isolation technology.
ARTBIO, a clinical-stage radiopharmaceutical company, is dedicated to pioneering targeted alpha radioligand therapies (ART), while SpectronRx is a developer and manufacturer of radiopharmaceuticals.
The centrepiece of the agreement entails SpectronRx taking on the responsibility of manufacturing a vital component of ARTBIO’s proprietary AlphaDirect system. This technology represents a breakthrough in the field, enabling the extraction of highly pure Pb212 from readily available raw materials.
Under the terms of this multi-year agreement, both companies will embark on an initial technology transfer and development phase. Following the completion of this phase, there will be a rigorous qualification process, ensuring the efficacy and quality of the technical components. Once the components meet the required standards, they will be released for deployment in ARTBIO’s AlphaDirect system, further advancing the development and availability of targeted alpha radioligand therapies.
SpectronRx co-founder and CEO John Zehner said: “We have a long history in managing complicated technology projects involving radioactive materials.
“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 AlphaDirect.”
ARTBIO is at the forefront of innovation with its groundbreaking AlphaDirect technology, introducing an optimized and proprietary Pb212 isotope isolation system that boasts several distinct advantages:
- Benchtop Format: The AlphaDirect technology is designed in a convenient benchtop format, making it highly versatile and adaptable for operation in facilities of any size. This flexibility enables widespread implementation across various medical and research settings, ensuring accessibility and ease of use.
- Simplicity and High Purity: One of the key highlights of AlphaDirect is its remarkably straightforward process. Unlike traditional methods, it does not require fluid separation, resulting in a remarkably high purity level of 99.9% or more. This exceptional purity is crucial for the success and efficacy of radiopharmaceutical therapies, ensuring accurate and precise treatment
- Streamlined Supply Chain: ARTBIO has ingeniously devised the AlphaDirect system to optimize the supply chain. By utilising starting materials derived from accessible nuclear industry stockpiles, uncertainties and costs are minimised. This streamlined approach guarantees a stable and reliable source of materials, contributing to consistent production and availability.
In this collaborative effort, SpectronRx brings its invaluable expertise in handling and manufacturing rare medical radioisotopes, specifically Ac-225 (actinium-225) and Pb-212, to the table. Their profound knowledge in this specialized area, along with their well-established infrastructure for Radiopharmaceutical Contract Development (rCDMO) and Radiopharmaceutical Contract Manufacturing (rCMO), adds immense value to the partnership.
The inclusion of these rare radioisotopes in SpectronRx’s repertoire enhances the capabilities of ARTBIO’s AlphaDirect technology, broadening the range of possibilities for targeted alpha radioligand therapies. By leveraging SpectronRx’s expertise, ARTBIO can effectively enhance and validate its manufacturing processes, ensuring they adhere to the highest standards.
Furthermore, SpectronRx’s extensive regulatory track record plays a vital role in the collaboration. With their proven experience in navigating regulatory requirements, the partnership gains a significant advantage in preparing for FDA and EMA (European Medicines Agency) reviews. This strategic advantage expedites the pathway to gaining necessary approvals and allows ARTBIO to accelerate the development and eventual commercialization of their groundbreaking radioligand therapies.
By combining the strengths of both companies, this partnership holds tremendous potential for advancing the field of radiopharmaceuticals, ultimately leading to the development of innovative treatments with the potential to transform medical care and improve patients’ lives.
ARTBIO CEO Emanuele Ostuni said: “We are pleased to partner with SpectronRx, a company with extensive experience and capabilities in managing nuclear chemistry projects.
“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 AlphaDirect technology. With SpectronRx’s expertise, we are a step closer to the establishment of the ARTBIO manufacturing network.”