News | Radiopharmaceuticals and Tracers | June 04, 2024

NorthStar Medical Radioisotopes Marks Critical Milestone in Readiness for Clinical Batch Production

Company’s first fully equipped cleanroom facility to support batch production for radiopharmaceutical clinical trials was completed in 6 months

NorthStar Operators Manufacture a Product Batch in New Cleanroom

NorthStar Operators Manufacture a Product Batch in New Cleanroom (Photo: Business Wire)

June 4, 2024 — NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used to detect and treat cancer and other serious diseases, today announced that it has completed and will commission a new cleanroom facility on its campus in Beloit, Wis. to support clinical trials. The completion, qualification and opening of the new cleanroom to support both current clinical trials and full-scale manufacturing that will commence in July of this year represents a key milestone in NorthStar’s effort to help accelerate and expand access to game-changing radiopharmaceuticals for patients around the world.

The processes to develop, manufacture and deliver therapeutically effective radiopharmaceutical medicines at a scale capable of meeting patient needs are specialized and complex. They include supporting and managing the detailed standard operating procedures, data collection and record-keeping processes required for submission of a product file to regulatory authorities for marketing approval. All of this is underpinned by NorthStar’s Quality Control lab and the adjacent new ISO-71 cleanroom suite. The suite includes:

Multiple shielded radiopharmaceutical ISO-52 enclosures including a shielded Biological Safety Cabinet3 and a shielded isolator4 -- specialized enclosures designed for safe and aseptic (contamination-free) preparation of sterile drug products which contain radioactivity.
A buffer and solution preparation space -- a work area within the cleanroom where operators can stage materials or weigh, adjust, and dissolve components used in the process.
Controlled entry – an entry room through which operators must pass before entering the cleanroom. This space is a buffer between normal air and cleanroom air, and also provides space for operators to put on sterile garments before entering the cleanroom.

The new suite supports core processes NorthStar will provide to help clients progress radiopharmaceuticals through various complex stages of drug development from clinical trials, regulatory filings and review, and if successful, regulatory approval and commercialization. These processes include initial tech transfer (moving production of a new drug from the lab making ‘research’ quantities into a manufacturing facility and establishing processes capable of supporting larger registration trials), and engineering/validation campaigns to confirm that these medicines are manufactured, packaged and distributed in a way that assures doctors and patients of their safety, efficacy, quality and potency. These NorthStar capabilities will expand further when its larger 52,000 sq ft., built-for-purpose CDMO facility opens later this year.

“Until recently, securing a reliable, seamless product supply for clinical trials and patient treatments was a significant hurdle for biopharmaceutical companies focused on identifying and developing effective new radiopharmaceutical agents”, said Frank Scholz, President and Chief Executive Officer of NorthStar. “NorthStar is uniquely equipped to help companies overcome that challenge,” he continued, “and as we demonstrated with construction of this new cleanroom, we can provide rapid response and turnaround to meet customer needs. We provide U.S.-based manufacturing of both therapeutic isotopes and cGMP patient-ready radiopharmaceutical products for support of clinical trial sites. 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’s vertically integrated manufacturing offers our partners significant manufacturing, supply chain and environmental advantages, including simplified logistics with minimal shipping requirements, efficient utilization of the radioisotope and a reduced carbon footprint.”

For more information: www.northstarnm.com

References:

1 ISO-7 cleanroom standards are set by the International Organization for Standardization (https://www.iso.org/standards.html). The ISO cleanroom classification system used in the United States is primarily for pharmaceutical cleanrooms, medical device cleanrooms, biotech cleanrooms, life-science cleanrooms, and USP797/800 compounding cleanrooms.
2 ISO 5 Class clean rooms, also known as Class 100 cleanrooms, are soft- or hard-sided wall manufactured structures that use HEPA filtration systems to maintain air cleanliness levels of a maximum of 100 particles (≥0.5 µm) per cubic meter of inside air.
3 An enclosure used to protect personnel against biohazardous or infectious agents and to help maintain quality control of the material being worked with as it filters both the inflow and exhaust air.
4 A specialized radiopharmaceutical enclosure that ensures a ‘laminar flow’ – providing clean air while simultaneously displacing potential particulate contamination so that the work zone remains clean.