R&D Department – ISOTOPIA
At ISOTOPIA, our Research and Development (R&D) department is the innovation engine behind our multiple breakthroughs in nuclear medicine. We focus on developing and optimizing radiopharmaceuticals—including PET and SPECT tracers—to advance cancer diagnosis and treatment globally.
How Our R&D Supports and Adds Value to Our Customers
Our expert team—combining vast scientific, technological, and regulatory experience—ensures that every ISOTOPIA product and service meets the highest standards of quality, efficacy, and compliance.
By tailoring radiopharmaceutical manufacturing processes to customer needs and emerging clinical demands, we provide healthcare professionals, researchers, and industry partners with safer, more reliable, and more cost-effective nuclear medicine solutions.
From early-stage concept to commercial-scale production, our R&D team partners with you at every step, offering:
- Comprehensive process development for new radiopharmaceuticals, with a focus on speed-to-market and seamless integration
- Regulatory support to ensure full compliance with international standards
- Continuous optimization for efficacy, yield, and product stability
- Responsive, customer-driven innovation to overcome new clinical and operational challenges
Core Areas of Expertise
Fluorine-18 (18F) Based Syntheses
- Automated 18F radiolabeling using advanced synthesis modules (TRASIS)
- Development of robust, scalable, and GMP-compliant manufacturing processes
Gallium-68 (68Ga) Based Syntheses
- Automated and kit-based 68Ga radiolabeling processes on dedicated modules
- Innovation of “Shake & Bake” kit formats for rapid, user-friendly, on-site radiopharmaceutical preparation
Technetium-99m (99mTc) Based Syntheses
- Development of ready-to-use “Shake & Bake” kits
- Expertise in lyophilization (freeze-drying) to extend shelf life and enhance product stability
Analytical Method Development
- Creation and validation of analytical methods for radiopharmaceuticals
- Dedicated support for Quality Control (QC) throughout R&D and commercial manufacturing phases
Showcasing Our Multidisciplinary Innovation
- Freeze-Dried Kit for Ga-PSMA-11
When developing Ga-PSMA-11, our R&D team eliminated unnecessary purification steps by utilizing the product’s high radiolabeling efficiency. Leveraging our experience in freeze-dried Tc-99m kit technology, we pioneered a novel “Shake & Bake” (ready-to-use format) lyophilized kit for Ga-PSMA-11—setting a new standard for gallium-based radiopharmaceuticals.
This optimized process resulted in:
- Shorter production timelines
- Increased batch capacity
- Enhanced accessibility for clinical application
- Consistent product quality and strict regulatory compliance
2. Innovative Kit for Lu-PSMA-I&T
Building on our success with lutetium production and kit formulation, our R&D team developed a straightforward, user-friendly “Shake & Bake” kit for Lu-PSMA-I&T that requires neither automation nor purification. This approach accelerates commercialization and empowers end-users by reducing their reliance on costly equipment
A Commitment to Collaborative Innovation
ISOTOPIA’s R&D department is committed to sustained innovation, multidisciplinary collaboration, and practical problem-solving that deliver immeasurable value to healthcare providers and patients alike.
By integrating scientific rigor with real-world manufacturing and regulatory guidance, we continuously create advanced nuclear medicine solutions that significantly improve clinical outcomes and drive operational excellence.
Partner with ISOTOPIA’s R&D team to accelerate your radiopharmaceutical development and unlock new and promising possibilities in nuclear medicine.
Contact us to learn how our R&D services and expertise can support your next project.