Radiopharmaceutical Therapy

Actinium-225

Actinium-225 (Ac-225) is considered one of the rarest radioisotopes on earth. It is not naturally occurring and therefore needs to be manufactured. There are several technologies used to produce Ac-225 but none that can scale to meet commercial quantities. NorthStar’s method is capable of meeting customer demand.

PRODUCING SUFFICIENT SUPPLY
TO MEET GLOBAL DEMAND

NorthStar is pioneering groundbreaking technology to produce commercial quantities of actinium-225 from radium-226 targets using electron beam accelerators. The process begins with the acceleration of an electron that collides with a converter. The converter absorbs the energy from the electrons, converting it into a high-energy photon that collides with the target material, removing a neutron from the nucleus of the atoms resulting in radium-225.

Next, a chemical purification process is completed removing all actinium, including actinium-227, leaving a purified radium solution. The purified radium solution is allowed to decay and produce non-carrier added (n.c.a.) Ac-225. This process substantially increases production capacity and flexibility due to multiple radium solutions being on-line simultaneously.

Radium solution used will be reclaimed and used again as future target material.

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Our Actinium-225
Fact Sheet

LEARN MORE ABOUT NON-CARRIER ADDED Ac-225

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We examine the various methods of producing Actinium-225 in our White Paper.

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THE RHODOTRON® TT-300 HE (HIGH ENERGY)
ELECTRON BEAM ACCELERATOR

NorthStar is using an electron accelerator, a first-in-kind technology, to produce n.c.a. Ac-225. High energy electron accelerators provide several advantages over other production methods. Accelerators have a relatively small footprint and are designed to operate for extended periods of time. They have the ability to produce commercial scale quantities of radioisotopes while using less power and starting material, without creating long lived byproducts. Choosing this technology is consistent with NorthStar’s commitment to greening healthcare.

NorthStar’s third electron accelerator, dedicated exclusively to the production of n.c.a. Ac-225, was delivered and installed in early 2023.

BUILDING A HOME FOR GLOBAL Ac-225 PRODUCTION

In September 2021, NorthStar held a groundbreaking ceremony on a 30,000 square foot facility dedicated to the production of commercial-scale n.c.a Ac-225 produced with a dedicated IBA Rhodotron® TT300-HE electron accelerator, delivered and installed in early 2023. The buildout of both internal and external infrastructure is nearly complete. The state-of-the-art radiochemistry lab is complete, and validations of redundant analytical equipment are underway.  The Rhodotron power supply, beamline, and target rooms are advancing as planned and the one-of-a-kind hot cell train footprint is in place. NorthStar expects initial radiochemical grade (RCG) production of n.c.a. Ac-225 in 2025 and filing of the drug master file for cGMP n.c.a. Ac-225 production in 2025. These timelines are dependent on supply chain execution from our various global vendors. NorthStar has a dedicated team working daily to maintain the timelines in an effort to have the greatest impact on patients.

TIMELINE

Sept 2021
Facility Groundbreaking
Nov 2021
Orders placed for accelerators and essential long-lead items
Early 2022
Construction begins
NOV 2023
Construction Completed
Q1 2025
Initial production of radiochemical grade Ac-225
LATE 2025
Drug Master File Submitted to FDA

Publicly announced
supply agreements

Multiple other supply agreements have been executed but not made public at this time

What is NON-CARRIER ADDED (n.c.a.)?

Sometimes, inactive materials are added to a radioactive substance to ensure that its radioactivity will behave normally in future chemical and physical processes. NorthStar’s Ac-225 is non-carrier added (n.c.a.), meaning no stable elements have been added in our process of producing or isolating Ac-225. Our production processes prevent the disposal and strictly regulated storage of long-lived Ac-227, which help to keep our Earth a little greener.