Advancing
Targeted
Radiotherapies

About Nucleus RadioPharma

Nucleus RadioPharma is a full-service Contract Development and Manufacturing Organization (CDMO) dedicated to building robust and reliable clinical and commercial supply chains for targeted radiotherapies.

Our vision is to bring these life-saving treatments to patients by offering:

Product Development and Regulatory Expertise that empower innovators to advance promising drug candidates into commercially successful medicines

Manufacturing Infrastructure that provides reliability, versatility, and efficiency

Supply Chain networks that meet the unique demands of radioactive isotope-based products

Unique Profile

Destination Medical Centers Connection
We are building our development and manufacturing facilities in proximity to prominent destination medical centers and key distribution hubs. Nucleus’ relationships will enable access to the world’s largest radiopharmaceutical clinical trial networks and provide timely delivery of short half-life theranostics products to patients.
End-to-End CDMO Support
Our technology platforms and drug development expertise provide clients with end-to-end support – including formulation and analytical development, regulatory documentation, drug product manufacturing, and distribution to patients.
Flexible Approach & Capacity
Innovators can come to us at any point in their product lifecycle and receive the optimal services that rapidly advance their program. Our CDMO services are flexible with multiple onboarding points, designed to expand in line with future demand.

A new tool in the fight against cancer

Radioligand therapy is a new and powerful precision technology in the fight against cancer.

Our Technology

A Radioligand therapeutic consists of three parts:

01
Ligand
A ligand is the peptide, small molecule, or antibody that targets and binds to a specific biomarker or receptor expressed by the cancer cell.

02
Linker
The linker contains a chelating agent or chemical bonding site that links the ligand to a radioactive isotope.

03
Radioactive Isotope
A radioactive isotope that emits high-energy (usually through the emission of alpha or beta particles) to kill the cancer cell through DNA damage.

Technology used to attach to Cancer Cell

The radiation from high-energy radioligand therapies only travels short distances, so binding the ligand to the cancer cell helps to ensure that only the cancer cell is damaged and limits damage to healthy tissues.

Another significant advantage to this technology is that the ligands target and bind to individual cancer cells wherever they are in the body. Even if the cancer has spread from the primary site, it can still be treated, often sooner than these micro-metastases would be detected by traditional imaging techniques.

The same technology can be used to image the cancer for diagnosis and monitoring. By replacing the alpha or beta particle emitting isotope with one that emits positrons or gamma rays, tumor sites can be detected using highly sensitive imaging technology. This concept is often called theranostics, a combination of diagnostics and therapeutics, which allows the physician to see exactly what they are treating.

Challenges in manufacture and supply

While radioligand therapies have shown significant clinical benefit, huge challenges exist in the supply chain for these life-saving treatments.

Our Challenges

Manufacturing capacity is a significant constraint for currently approved radioligand therapies, and with hundreds of new theranostics clinical trials ongoing, the science has rapidly outpaced the supply chain. As these promising therapies get approved for more indications and for treatment of earlier stages of disease, this pressure will only increase.

The half-life of the radioisotope adds an additional challenge to the supply chain, due to the extremely limited shelf-life of the radioisotope and the final therapeutic product. The clock starts ticking on shelf-life from the moment the radioactive isotope is isolated and purified. From this point there may only be days, or sometimes even hours, to manufacture, release, ship and administer a dose to a patient.

Nucleus RadioPharma's Solution

Nucleus RadioPharma has been established with capacity, quality and supply chain resilience in mind.

Our Solution

Our initial facility will be located in Rochester, Minnesota, followed by other destination medical centers and distribution hubs in the USA, and ultimately worldwide.

Manufacturing suites will be purpose built to comply with FDA guidance 211 for therapeutic products, and new facility builds will be phased in line with demand as new radiotherapeutics are released or reach later phase clinical trials, ensuring that manufacturing capacity increases with demand.