Ilumira (n.c.a. lutetium-177; Lu-177) is a powerful radioisotope that is revolutionizing cancer care. When paired with a cancer-seeking molecule, Ilumira precisely targets tumors and metastases, delivering a potent dose of radiation to kill cancer cells while minimizing harm to healthy tissue.
Ilumira is the active pharmaceutical ingredient showing promise in the fight against various cancers, including neuroendocrine tumors and prostate cancer. Its targeted approach makes it a valuable tool for patients who have not responded well to other treatments. By delivering radiation directly to cancer cells, Ilumira offers new hope for patients with advanced or difficult-to-treat cancers, potentially improving outcomes and quality of life.
Unmatched Quality: Our proprietary production process yields high specific activity n.c.a. Lu-177 and exceeds US and European Pharmacopeia standards, creating optimal efficacy and safety.
Reliable Domestic Supply: SHINE’s U.S.-based manufacturing facility is GMP-validated for domestic continuous supply, reducing the risk of supply shortages or disruptions.
Fast, Weekly Shipping: Ilumira (n.c.a. Lu-177) is available now. We ship every week from the heart of the Midwest so you can keep your research and clinical trials on track.
Regulatory Compliance: We adhere to current Good Manufacturing Practices (cGMP) and have filed our Drug Master File (DMF) with the FDA.
Our supply chain is entirely U.S.-based from start to finish. We do not rely on Yb-176 starting material from Russia or the aging European reactor network for irradiation in our vertically integrated process. By eliminating our dependency on other sources, we can produce more readily available product. This de-risks supply for customers with a totally separate supply chain from established suppliers.
Our commitment to innovation, quality, and self-sufficiency sets us apart from the competition. We're leading the charge in revolutionizing cancer care by developing a reliable and efficient supply chain for this vital radioisotope. Here's how we're achieving that:
Vertical Integration: We're one of the only producers of ytterbium-176 outside of Russia. We’re on our way to becoming the world's first vertically integrated manufacturer of Lu-177.
Purpose-built Facility: We adhere to ICH Q7 and FDA 21CFR guidelines, with a Drug Master File ready for cross-referencing.
Individual Testing: We rigorously test each lot of lutetium-177 to ensure optimal radio-labeling yield and performance.
Highest Production Capacity in the U.S.: Enables production of millions of cancer-fighting doses annually.
Packaging Options
10 mL flat bottom vial
2mL conical glass vial
Chemical form
n.c.a. 177LuCl₃ in 0.04M HCI solution
specific activity
≥3,000 GBq/mg at SHINE calibration time
Radiochemical Purity
≥99% as 177LuCl₃
Radionuclidic Purity
≥99.9% 177Lu
Radioactivity Concentration at SHINE Calibration Time
1.0Ci/mL (37GBq/mL) +/-10%
Expiry
10 days from the end of synthesis
Standard Calibration Time
Tuesdays 1200 central time (U.S) at 1Ci/mL
cGMP
Meets ICH-Q7 and FDA-21CFR
Radiolabeling Yield
≥ 99%
Ilumira’s purity and quality are unmatched. With SHINE's domestically-produced, high-specificity Lu-177, you have the power to create a brighter future for cancer patients.
Ready to transform cancer treatment? Contact us today to discover how SHINE's Lu-177 can help you develop the next generation of targeted therapies.
Email us at Ilumira@shinefusion.com
