NorthStar Medical Radioisotopes has completed and will commission a new cleanroom facility on its campus in Beloit, Wisconsin, US, that will be used to support both current and clinical trials.
The US-based company is an innovator in the development, production, and commercialisation of radiopharmaceuticals used to detect and treat cancer and other serious diseases.
The completion, qualification, and opening of the new cleanroom will be for full-scale manufacturing and will commence in July.
The new suite supports core processes that NorthStar will provide to help clients progress radio-pharmaceuticals through various complex stages of drug development
This cleanroom facility represents a key milestone in NorthStar’s effort to help accelerate and expand access to game-changing radiopharmaceuticals for patients worldwide.
The processes to develop, manufacture, and deliver therapeutically effective radiopharmaceutical medicines at a scale capable of meeting patient needs are specialised and complex, which 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
The above process is underpinned by NorthStar’s Quality Control lab and the adjacent new ISO Class 7 cleanroom suite, which includes:
- Multiple shielded radiopharmaceutical ISO Class 5 enclosures including a shielded Biological Safety Cabinet (BSC) and a shielded isolator — specialised enclosures designed for safe and aseptic (contamination-free) preparation of sterile drug products that contain radioactivity.
- A shielded BSC: 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
- A shielded isolator: A specialised radiopharmaceutical enclosure that ensures a ‘laminar flow’ – providing clean air while simultaneously displacing potential particulate contamination so that the work zone remains clean
- 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 that NorthStar will provide to help clients progress radio-pharmaceuticals through various complex stages of drug development from clinical trials, regulatory filings, and review, and if successful, regulatory approval and commercialisation.
The processes include engineering/validation campaigns to confirm that these medicines are manufactured, packaged, and distributed in a way that assures doctors and patients of their safety
These processes include initial tech transfer, which is 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.
The processes also include 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 sqft built-for-purpose CDMO facility opens later this year.
Frank Scholz, President and CEO of NorthStar, said: “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.”
A shielded isolator is a specialised radiopharmaceutical enclosure that ensures a ‘laminar flow’
“NorthStar is uniquely equipped to help companies overcome that challenge and as we demonstrated with construction of this new cleanroom, we can provide rapid response and turnaround to meet customer needs,” Scholz continued.
“We provide US-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,” Scholz added.
“NorthStar’s vertically integrated manufacturing offers our partners significant manufacturing, supply chain and environmental advantages, including simplified logistics with minimal shipping requirements, efficient utilisation of the radioisotope and a reduced carbon footprint,” Scholz concluded.
