Smarter cancer therapy, now available
Lutetium-177
n.c.a. lutetium-177 (Lu-177) is a powerful radioisotope that is revolutionising cancer care. When paired with a cancer-seeking molecule, Lu-177 precisely targets tumors and metastases, delivering a potent dose of radiation to kill cancer cells while minimizing harm to healthy tissue.
VERTICALLY INTEGRATED PRODUCTION
Readily Available Product
SHINE’s vertically integrated supply chain ensures consistent uptime and steady supply. SHINE is developing in-house capabilities for Yb-176 production and irradiation, reducing reliance on external sources. This approach de-risks supply for customers with a separate supply chain from established suppliers, ensuring product availability worldwide.
STEADY UPTIME, GLOBAL IMPACT
Lu-177: Revolutionising Cancer Care
Lu-177 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, Lu-177 offers new hope for patients with advanced or difficult-to-treat cancers, potentially improving outcomes and quality of life.
Unmatched Quality: SHINE’s 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: SHINE’s n.c.a. Lu-177 is available now. SHINE ships every week from the heart of the Midwest so you can keep your research and clinical trials on track.
Regulatory Compliance: SHINE adheres to current Good Manufacturing Practices (cGMP) and has filed its Drug Master File (DMF) with the FDA.
Pioneers in Lu-177 Production
SHINE’s commitment to innovation, quality, and self-sufficiency sets us apart from the competition. SHINE is leading the charge in revolutionizing cancer care by developing a reliable and efficient supply chain for this vital radioisotope. Here’s how SHINE is achieving that:
Vertical Integration
SHINE is 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, ensuring steady supply.
Purpose-built Facility
SHINE adheres to international quality standards, ensuring consistent, high-quality production
Individual Testing
SHINE rigorously tests each lot of lutetium-177 to ensure optimal radio-labeling yield and performance
Production Capacity
n.c.a. Lutetium 177 Product Specifications
| Parameter | Details |
|---|---|
| Packaging Options | 10 mL flat bottom vial 2 mL 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 | 1.0 Ci/mL (37 GBq/mL) ± 10% |
| Expiry | 10 days from the end of synthesis |
| Standard Calibration Time | Tuesdays 12:00 Central Time (U.S) at 1.00 Ci/mL |
| cGMP | Meets ICH-Q7 and FDA-21CFR |
| Radiolabeling Yield | ≥ 99% |