NorthStar opens new cleanroom to support radiopharmaceutical clinical trials

por Gus Iversen, Editor in Chief | June 07, 2024
Molecular Imaging
NorthStar's newly commissioned cleanroom ready for operations in Beloit, WI
NorthStar Medical Radioisotopes has completed and commissioned a new cleanroom facility at its Beloit, Wisconsin campus to support radiopharmaceutical clinical trials and full-scale manufacturing.

The development and delivery of radiopharmaceuticals require complex specialized processes, which the ISO-71 certified cleanroom suite, alongside its Quality Control lab, will support. The suite, which will become operational in July, features:

Shielded radiopharmaceutical ISO-52 enclosures: These include a Biological Safety Cabinet and a shielded isolator for safe and sterile preparation of radioactive drug products.
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Buffer and solution preparation space: This area is designed for staging materials and preparing components used in manufacturing.
Controlled entry: This buffer zone ensures sterile conditions by providing a space for operators to put on sterile garments before entering the cleanroom.

These capabilities are crucial for moving drug production from research to manufacturing scale, supporting regulatory filings, and ensuring the safety, efficacy, quality, and potency of the radiopharmaceuticals.

In a statement, Frank Scholz, president and CEO of NorthStar, described the advantages of the company's vertically integrated manufacturing. These include simplified logistics with minimal shipping requirements, efficient utilization of the radioisotope and a reduced carbon footprint.

"We provide U.S.-based manufacturing of both therapeutic isotopes and cGMP patient-ready radiopharmaceutical products for support of clinical trial sites," Scholz said. "And as our customers’ targets go through the registration process and are approved, NorthStar will work with them to be able to scale up and provide large-scale patient dosing."

NorthStar produces radioisotopes for cancer detection and treatment, and is expanding its capabilities to include non-carrier-added actinium-225. Last month, the company tapped Veritas Shielding Solutions to help establish a radiation-shielded facility to manufacture concentrated quantities of the radiopharmaceutical.

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