Radiopharmaceuticals consist of radioactive isotopes that are chemically attached to small molecules, peptides or protein drugs such as antibodies. These treatments are rapidly gaining traction in the treatment of cancer for their ability to zap tumors with deadly targeted radiation, and they depend on the scalable production of medical isotopes including Copper-67 (Cu-67) and Actinium-255 (Ac-225).
However, the complexities of radiopharmaceuticals in addition to the expertise and facilities required to develop them means that biopharma companies “don’t have the specialized skills or processes necessary to deliver these medicines, particularly when they are still in clinical trials,” said Frank Scholz, president and CEO of NorthStar in a public statement, adding that the companies “understand that it is not realistic or financially viable to do it themselves.”
NorthStar’s new 52,000 square-foot (4,830 square-meter) facility is intended to address the growing demand for these radioisotopes by guiding the development of radiopharmaceutical drugs for its client pharma and biopharma companies and letting NorthStar add more services to its offerings.
NorthStar was founded in 2006 and has raised more than $117 million in grants and equity financing, according toCrunchbase. The company specializes in the production of radioisotopes including Ac-225, Lu-177, Cu-64, Cu-67, and In-111.
With the new facility in place, NorthStar touts itself as the only U.S. company to have “co-located, commercial scale multi-radioisotope production and radiopharmaceutical manufacturing.”
The increasing integration of medical radioisotopes with diagnostic and molecular imaging as well as the rise of personalized medicine is spurring the growth of the global market for these products, which was valued at $5.1 billion in 2022 and is expected to soar by 8.8% per year to $11.4 billion by 2032. NorthStar’s peers in the field include Nordion, Isotopen Technologien München (ITM) and Curium.
Radiopharmaceuticals in particular are attracting major big pharma interest with recent deals including the acquisition of Fusion Pharmaceuticals by AstraZeneca for up to $2.4 billion and Novartis snapping up Mariana Oncology for up to $1.75 billion.
“The last several years have seen an explosion of research and clinical trials in this area, and yet today there are still far, far too few effective therapies for the many diseases like cancer without effective treatments and the many patients who need them,” Scholz told Outsourcing Pharma in an email.
The technical complexity of developing radiopharmaceuticals is not the only obstacle to the industry. These therapies must be regulated by not just national health systems, but also by nuclear security agencies and provincial laws, Scholz said, adding that radiopharmacueticals have a limited shelf life, requiring expert management of the supply chain. Furthermore, the main source of crucial radioisotopes are nuclear reactors outside of the U.S., which are aging and are historically unreliable, he added.
NorthStar uses electron accelerator processes to produce Cu-67 and Ac-225 that scalably produce the goods at a commercial scale. They also do not require nuclear reactors, thereby reducing the production of radioactive waste.
The opening of NorthStar’s facility occurs in the same week that another CDMO, Nucleus RadioPharma expanded two sites in the U.S. to triple its production capacity and add 100 jobs to its roster. Meanwhile, the firm SpectronRx is set to build a production facility in Belgium after striking a partnership with the Belgian Nuclear Research Center.
