One of the fastest-growing segments in the life sciences industry is that of radiopharmaceuticals, or what some call nuclear medicine. The global market for radiopharmaceuticals was valued at $6.1 billion in 2019 and is estimated to reach $12.6 billion by 2027. However, for traditional pharmaceutical companies, moving into the world of radiopharmaceuticals can be a daunting task.

Radiopharmaceuticals are highly specialized and require equipment, facilities, personnel, licensing and training that is significantly different from traditional pharmaceutical manufacturing. This makes the in-house development and manufacturing of radiopharmaceuticals extremely cost-prohibitive for both small and large-scale life sciences companies. But despite operational costs, there are huge advantages to radiopharmaceuticals, because their radioactivity allows non-invasive external monitoring or targeted therapeutic irradiation with very little effect on the biologic processes in the body. Novartis highlighted the value of this in 2017 when it acquired Advanced Accelerator Applications for $3.9 billion.

In addition to the potential of having to shell out a lot of money to buy such companies, building radiopharmaceutical teams and facilities from the ground up can greatly impact time-to-market and increases the margin for error. This is why a majority of the life sciences companies looking to develop and manufacture radiopharmaceuticals are opting to work with Contract Development and Manufacturing Organizations (CDMOs) like SpectronRx, which specializes in regulatory services, early stage development, and both clinical trial supply and commercial supply of radiopharmaceuticals.

SpectronRx specializes in dozens of therapeutic and diagnostic isotopes, including Lu-177 (Lutetium), which is one of the more sought-after isotopes when it comes to the treatment of certain cancers.

“Lu-177 therapies will grow to be a multi-Billion market over the next few years, with more than 21 Lu-122 labeled drugs currently at clinical stage,” said John Zehner, CEO of SpectronRx in a phone interview. “Based on how these clinical trials are progressing, we are seeing increased demand for lutetium radiolabeled therapeutics.”

Y-mAbs Therapeutics recently partnered with SpectronRx to secure access to clinical and commercial-scale radiolabeling capacity for its monoclonal antibody, Omburtamab. Y-mAbs Therapeutics, is a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer.

As part of the agreement, SpectronRx has established both a clinical and commercial manufacturing team specifically designated for Y-mAbs’ products within its existing facilities. Both the clinical and commercial supplies of radiolabeled Omburtamab are being produced for Ymabs by SpectronRx in individual sterile suites. The agreement between Y-mAbs and SpectronRx is designed to secure clinical and commercial scale radiolabeling capacity for Omburtamab, and allows for supply to the US market upon potential FDA approval of radiolabeled Omburtamab. One of their facilities will also serve as a back-up for Y-mAbs overseas activities.

FDA recently cleared YmAb’s Lutetium-177 that is labeled Omburtamabfor the treatment of B7-H3 positive Central Nervous System (CNS) and Leptomeningeal Metastasis (LM) from tumors in adult patients.

SpectronRx provided the CMC documentation as well as the clinical supply of Lu-177 for this significant milestone. This product has also been cleared by the FDA for use in pediatric and adolescent patients for treatment of recurrent or refractory Medulloblastoma in a separate clinical trial.

“SpectronRx understands the various methods of production of multiple isotopes, including Lu-177, from both a reactor and an accelerator. These isotopes are used in therapeutics and diagnostics,” Zehner added. “We continuously work to ensure availability of isotopes to help expand access to patients of these life-saving therapies utilizing Lu-177 and other labeled radiopharmaceuticals.”

Another up and coming radiopharmaceutical CDMO is Evergreen Theragnostics, which was founded in 2019. Evergreen broke ground for its new manufacturing plant in Springfield, New Jersey in September. The new facility will be 14,000 square feet and is designed from start to finish to meet global standards for radiopharmaceutical manufacturing. This includes both therapeutic and centrally distributed diagnostic radiopharmaceuticals.

In a recent news release, James Cook, chief executive officer of Evergreen said, “We are excited to take one more step forward in realizing our goal of providing high quality and high reliability manufacturing of radiopharmaceuticals in North America. We are encouraged to see companies in our industry developing so many exciting new drugs, and are eager to provide a top-tier manufacturing service to support their efforts.”

The facility will have four fully equipped production suites and three additional customizable suites, in addition to research facilities, multiple sterility lines, quality control, material storage and packaging space. The new facility is expected to open in 2021 and provide manufacturing services for radiopharmaceuticals at all stages.

Outsourcing development and manufacturing services for radiopharmaceuticals allows pharmaceutical companies to focus on their core business, which can help them greatly reduce costs, time-to-market and risk. The advantages of developing more radiolabeled therapeutics is becoming clearer which results in more and more traditional pharmaceutical companies expanding their current pipeline with Radiopharmaceuticals which increases the need for assistance with the ins and outs associated with running a radiopharmaceutical program.

Another big advantage of working with a CDMO that specializes in radiopharmaceuticals is that they can ensure the commercial supply and delivery of these essential diagnostics and therapeutics. Manufacturing for clinical supply has its own nuances, but ensuring that commercial supply can be delivered once a drug is approved is an even bigger task.

“When evaluating CDMOs, the manufacturing side of the equation is equally as important as the development side,” said SpectronRx President Anwer Rizvi, in a phone interview. “When you are talking about hundreds, if not thousands of patients, counting on your specialized therapy for lifesaving treatment, the last thing you want is supply chain issues.”

As the fledgling radiopharmaceutical CDMO market continues to mature, more and more pharmaceutical companies will come to rely on their services. More radiopharmaceutical partnerships are expected to be announced in the future.

Photo: Dmitrii_Guzhanin, Getty Images