Clinical Scale Manufacturing
Introducing The SPICA Center
Driven by innovation, we have built a full-service, self-sufficient facility in Houston, Texas, that integrates cutting-edge cGMP infrastructure, advanced isotope production, and deep regulatory expertise. Conceived from best practices, the SPICA Center is purposefully designed to lead the industry in time-to-market, quality, and volume—delivering high-quality radiotherapeutics at both clinical and commercial scale. Our state-of-the-art facility is in full compliance with 21 CFR 211. Partnering with RadioMedix ensures a meticulous manufacturing process, a reliable supply chain, and a team of safety-committed experts with a wealth of experience. Whatever your radiopharmaceutical needs, RadioMedix is open for business.
Our Expertise
Experience Unmatched Solutions in Manufacturing
When it comes to clinical trials, our team of scientists are prepared to meet your manufacturing needs including radiochemistry solutions, analytical method developments, process validation, manufacturing and testing under GMP guidelines. Our team is prepared and understands industry standards.
Your Trusted Partner in Manufacturing
At RadioMedix, we believe that quality and reliable partnerships are the cornerstones of successful clinical development. Our dedicated team combines cutting-edge technology with decades of expertise to deliver precision in every step of the manufacturing process. With our focus on safety and compliance, you can rest assured that your project is handled with the utmost care and proficiency.
“RadioMedix is redefining patient care with end-to-end manufacturing solutions that bring treatments from bench to bedside.”
— Ayda Delpassand, MSRS, MSGM,
Director of Business Development and Project Management
Why Choose Us?
We operate within a 27,500 SQFT large-scale commercial pharmaceutical manufacturing space, featuring a high-value packaging corridor. Our facility is designed to support scalable production, capable of handling multi-probe diagnostics and therapeutic agents for commercialized and centralized manufacturing and distribution—both throughout North America and globally.
Our Modular Production Suite consists of six aseptic clean rooms, each with a shared technical room to support efficient and compliant operations.
The Quality Control (QC) Laboratory includes two dedicated labs equipped with advanced analytical capabilities such as ICP-MS, HPLC, HPGe, and iTLC. A separate sterility lab ensures rigorous microbial testing and product safety.
Our Key Benefits
Choosing RadioMedix means opting for advanced solutions in manufacturing. With the support of a highly skilled team of 40 dedicated professionals, RadioMedix is committed to driving innovation in radiopharmaceutical manufacturing while maintaining rigorous quality and safety standards. Discover how we’re shaping the future of nuclear medicine with expertise and excellence. Our adaptable manufacturing strategies ensure that no matter how your project evolves, we have the right solutions ready for you.
Unwavering Commitment to Quality
At RadioMedix, quality assurance isn’t just a process—it’s a philosophy embedded in every facet of our operations. Our stringent quality control measures ensure we exceed industry standards and maintain product safety.
Continuous Improvement
Our team engages in ongoing training and the latest technologies to continually refine our practices. We prioritize transparency to strengthen our quality assurance protocols.
Client-Centric Management
We closely collaborate with our clients, tailoring our quality measures to their project needs, ensuring an effective and personalized approach.
Frequently asked questions
RadioMedix has manufacturing experience with entire value chain from drug discovery to sponsoring and conducting clinical trials to scale up manufacturing. RadioMedix is compliant with 21 CFR Parts 210,211,212.
Yes, RadioMedix works with the full spectrum of medical isotope applications
RadioMedix focuses on long-lived isotopes such as 177Lu, 225Ac, and 212Pb among others
RadioMedix can accommodate any batch-size from a single dose to larger lots and has the capacity to scale and automate to meet both early clinical development to commercial scale
RadioMedix has 7 cGMP manufacturing suites with full supporting analytical QC services. Please see our Manufacturing tab for a full list of equipment
RadioMedix is fully cGMP compliant and operates under a rigorous electronic Quality Management System (QMS).
RadioMedix can support phase appropriate clinical manufacturing at all stages of development
