CDMO/CMO | NorthStar Medical Radioisotopes, LLC

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class="h_intro_box_inner"> <p>NorthStar Medical Radioisotopes is a leader in novel, domestic and environmentally preferred radioisotope development and production. Technologies that advance the availability of radiopharmaceuticals are increasingly critical for the treatment of cancer. NorthStar鈥檚 patient-focused Radiopharmaceutical Contract Development and Manufacturing Organization (CDMO/CMO) addresses this important need.</p> </div> </div> </div> </div> </section> </div> </section> <section class="section-bg " > <div class="parallax-container section-parallax" data-parallax="scroll" data-position="top" data-bleed="10" data-image-src="https://www.northstarnm.com/wp-content/uploads/2022/12/bg-purple.jpg" data-natural-width="2000" data-natural-height="1411"></div> <div class="section-content "> <section class="m5_img_text py-tall"> <div class="container"> <div class="m5-img-text-inner bg-white"> <div class="m5-img"> <img src="https://www.northstarnm.com/wp-content/uploads/2024/10/DJI_0715-cropped1-scaled.jpg" alt="" class="img-fluid w-100" /> </div> <div class="m5-img-text-inner-content p-4 p-lg-5"> <div class="m5-title"> <h2 class="mb-2 xbright-purple">FROM DEVELOPMENT TO COMMERCIALIZATION</h2> </div> <div class="m5-content"> <p>Our comprehensive services support collaborator companies by providing customized solutions to help navigate the complex radiopharmaceutical development and manufacturing process. NorthStar鈥檚 Radiopharmaceutical CDMO/CMO services span the spectrum of radioisotope drug development, from research and scale-up through commercialization, and all are designed to meet rigorous clinical trial and patient use requirements. Our proven expertise in innovation, engineering, manufacturing, quality assurance and quality control, adherence to regulatory standards, and logistics are applied to meet each customer鈥檚 specific needs.</p> <p><strong>R&D contract manufacturing services are currently available.</strong></p> </div> </div> </div> </div> </section> </div> </section> <section class="section-bg " style="background-image: url(https://www.northstarnm.com/wp-content/uploads/2024/06/bg-featured-content-scaled.webp);" > <div class="parallax-container section-parallax" data-parallax="scroll" data-position="top" data-bleed="10" data-image-src="https://www.northstarnm.com/wp-content/uploads/2022/12/bg-purple-fade.jpg" data-natural-width="1573" data-natural-height="811"></div> <div class="section-content "> <div class="r16_featured_content py-tall"> <div class="bg-img-d d-none d-md-block bg-right"> <img src="https://www.northstarnm.com/wp-content/uploads/2024/06/bg-row-1-final.webp" alt="" height="1067px" width="1600px" loading="lazy" /> </div> <div class="bg-img-m d-block d-md-none"> <img src="https://www.northstarnm.com/wp-content/uploads/2024/06/bg-row-1-m.webp" alt="" height="467px" width="700px" loading="lazy" /> </div> <div class="container white"> <div class="row"> <div class="col-md-6"> <h2 class="mb-4"><span>Services</span></h2> <div class="r16_content"> <ul> <li>Programs designed for radiopharmaceuticals and radioactive medical devices</li> <li>Radionuclide supply: internal production or external procurement</li> <li>Alpha, beta and gamma flexibility and capabilities</li> <li>Test methods, formulation, process development & optimization</li> <li>Batch scale-up and process automation</li> <li>Technology transfer and integration efficiencies</li> <li>Stability assessment and stability program management</li> <li>Packaging and labeling development (vials and syringes)</li> <li>Fully dedicated logistics team 24/7</li> </ul> </div> <div class="r16_download mt-4"> <a href="https://www.northstarnm.com/wp-content/uploads/2024/06/NorthStar-CDMO-Fact-sheet-May-2024.pdf" target="_blank"> <div class="download-icon"> <img decoding="async" class="w-100 img-fluid" src="/wp-content/uploads/2024/06/icon-pdf-w.svg" alt=""> </div> <div class="download-text"> <div class="download-title">Download</div> <div class="download-description"> OUR CDMO/CMO FACT SHEET </div> </div> </a> </div> </div> </div> </div> </div> <div class="r16_featured_content py-tall"> <div class="bg-img-d d-none d-md-block bg-left"> <img src="https://www.northstarnm.com/wp-content/uploads/2024/06/bg-row-2-final.webp" alt="" height="900px" width="1600px" loading="lazy" /> </div> <div class="bg-img-m d-block d-md-none"> <img src="https://www.northstarnm.com/wp-content/uploads/2024/06/bg-row-2-m.webp" alt="" height="394px" width="700px" loading="lazy" /> </div> <div class="container white"> <div class="row"> <div class="col-md-6 offset-md-6"> <h2 class="mb-4">Facilities and<br><span>Equipment</span></h2> <div class="r16_content"> <ul> <li>55-acre campus designed with a purpose</li> <li>52,000 sq ft, fully-equipped radiopharmaceutical CDMO/CMO facility with immediate expansion opportunities</li> <li>Full service analytical and microbiological laboratories</li> <li>Redundancy of equipment, capabilities, personnel, and power</li> <li>R&D, preclinical, and early phase development suites</li> <li>Phase I, II and III clinical trial manufacturing</li> <li>Flexible cGMP suites fully-equipped for alpha/beta/gamma</li> <li>Clinical unit dose preparation (vials and syringes)</li> <li>Type A packaging and DOT-certified shipping with cold chain capabilities</li> <li>Dedicated office space on site for sponsor access</li> </ul> </div> <div class="r16_link mt-4"> <a href="https://www.northstarnm.com/company/facilities/" target="">Learn More About Our Facilities</a> </div> </div> </div> </div> </div> <div class="r16_featured_content py-tall-t-xtall-b"> <div class="bg-img-d d-none d-md-block bg-right"> <img src="https://www.northstarnm.com/wp-content/uploads/2024/06/bg-row-3-final.webp" alt="" height="1067px" width="1600px" loading="lazy" /> </div> <div class="bg-img-m d-block d-md-none"> <img src="https://www.northstarnm.com/wp-content/uploads/2024/06/bg-row-3-m.webp" alt="" height="467px" width="700px" loading="lazy" /> </div> <div class="container white"> <div class="row"> <div class="col-md-6"> <h2 class="mb-4"><span>Quality Assurance</span></h2> <div class="r16_content"> <ul> <li>cGMP-compliant (Title 21 CFR Parts 210/211) Quality Management System (QMS)</li> <li>Periodic internal audits and sponsor qualifications</li> <li>Integrated quality event and complaint handling procedures, including investigation, tracking, trending, and reporting</li> </ul> </div> <div class="r16_link mt-4"> <a href="https://www.northstarnm.com/radiopharmaceutical-therapy/why-northstar/" target="">DISCOVER MORE ABOUT CHOOSING NORTHSTAR</a> </div> </div> </div> </div> </div> <div class="r16_featured_content py-xtall"> <div class="bg-img-d d-none d-md-block bg-left"> <img src="https://www.northstarnm.com/wp-content/uploads/2024/06/bg-row-4-final.webp" alt="" height="1068px" width="1600px" loading="lazy" /> </div> <div class="bg-img-m d-block d-md-none"> <img src="https://www.northstarnm.com/wp-content/uploads/2024/06/bg-row-4-m.webp" alt="" height="467px" width="700px" loading="lazy" /> </div> <div class="container white"> <div class="row"> <div class="col-md-6 offset-md-6"> <h2 class="mb-4"><span>Regulatory Affairs</span></h2> <div class="r16_content"> <ul> <li>Regulatory and administrative services to support Investigational New Drug Application (IND), New Drug Application (NDA) and Drug Master File (DMF)</li> <li>Ability to author, publish and submit sections of the Common Technical Document (CTD)</li> <li>EU-dedicated CMO suite (EudraLex Vol. 4)</li> </ul> </div> <div class="r16_link mt-4"> <a href="https://www.northstarnm.com/company/leadership/" target="">MEET THE TALENTED PEOPLE WHO LEAD NORTHSTAR</a> </div> </div> </div> </div> </div> </div> </section> <section class="section-bg " > <div class="parallax-container section-parallax" data-parallax="scroll" data-position="top" data-bleed="10" data-image-src="https://www.northstarnm.com/wp-content/uploads/2022/12/bg-purple-fade.jpg" data-natural-width="1573" data-natural-height="811"></div> <div class="section-content "> <section class="module-timeline"> <div class="container"> <div class="row"> <div class="col-md-3"> <h2 class="title mb-4 text-white">TIMELINE</h2> </div> <div class="col-md-9"> <div class="timeline-container theme-white-pink-blue"> <div class="timeline-item status-complete"> <div class="timeline-date"> Oct 2022 </div> <div class="timeline-status"> <div class="timeline-status-inner"> <i class="fa-sharp fa-solid fa-check"></i> </div> </div> <div class="timeline-content"> Facility Groundbreaking </div> </div> <div class="timeline-item status-complete"> <div class="timeline-date"> Early 2023 </div> <div class="timeline-status"> <div class="timeline-status-inner"> <i class="fa-sharp fa-solid fa-check"></i> </div> </div> <div class="timeline-content"> Construction begins </div> </div> <div class="timeline-item status-complete"> <div class="timeline-date"> July 2024 </div> <div class="timeline-status"> <div class="timeline-status-inner"> <i class="fa-sharp fa-solid fa-check"></i> </div> </div> <div class="timeline-content"> Construction complete </div> </div> <div class="timeline-item "> <div class="timeline-date"> Jan 2025 </div> <div class="timeline-status"> <div class="timeline-status-inner"> </div> </div> <div class="timeline-content"> CDMO/CMO Production Operations Launch </div> </div> </div> </div> </div> </div> </section> </div> </section> <section class="section-bg " style="background-image: url(https://www.northstarnm.com/wp-content/uploads/2024/06/bg-purple-wave.webp);" > <div class="section-content "> <div class="r17_full_img_text"> <div class="r17-img"> <img src="https://www.northstarnm.com/wp-content/uploads/2024/10/facilities-10222024-labeled-1.webp" alt="" height="768px" width="1400px" loading="lazy" class="img-fluid w-100" /> </div> <div class="r17-content"> <div class="container p-5 white"> <p>NorthStar will be the first and only U.S. company housing commercial-scale, multi-radioisotope production radiopharmaceutical development services on the same campus. This enables collaborator companies to realize logistical, regulatory and cost benefits.</p> </div> </div> </div> </div> </section> <section class="section-bg bg-dk-blue-gray" > <div class="section-content "> <section class="r7_row_multicolumns py-0 footer-cta" > <div class="container"> <div class="row"> <div class="col-12 relative d-flex flex-column "> <div class="row py-short align-items-center "> <div class="col-md-4 "> <h2 class="title mb-4 "> PARTNERING WITH<br><span>NORTHSTAR</span> </h2>  </div> <div class="col-md-3 text-center"> <div class="featured-img"> <img src="https://www.northstarnm.com/wp-content/uploads/2022/12/circle-lab.png" class=" w-75 img-fluid mb-5 mb-lg-0" alt="" /> </div> </div> <div class="col-md-5 "> <div class="copy mb-4 mb-md-0"> <p>For more information, please contact <span class="nowrap"><a class="white" href="/cdn-cgi/l/email-protection#1073747d7f507e7f626478636471627e7d3e737f7d"><span class="__cf_email__" data-cfemail="8eedeae3e1cee0e1fcfae6fdfaeffce0e3a0ede1e3">[email protected]</span></a></span>, and visit us here to learn about the continued progress of NorthStar鈥檚 Radiopharmaceutical CDMO/CMO.</p> </div>  </div> </div> </div> </div> </div> </section> </div> </section> </div> <footer class="py-5"> <div class="container"> <div class="row"> <div class="col-12 col-md-4 mb-4 mb-md-0 py-md-2"> <p class="footer-brand"><img src="https://www.northstarnm.com/wp-content/themes/northstar/img/logo-w.svg" alt="NorthStar Medical Radioisotopes, LLC" class="w-100 img-fluid" /></p> <div class="contact-box"> <p>1800 Gateway Boulevard<br /> Beloit, WI 53511<br /> <strong>Phone:</strong> <a href="tel:8444386659">(844) 438-6659</a><br /> <strong>Phone:</strong> <a href="tel:6083138000">(608) 313-8000</a></p> </div> </div> <div class="col-md-4 py-md-2 mb-4 mb-md-0"> <div class="menu-main-menu-container"><ul id="menu-main-menu-2" class="menu" itemscope itemtype="http://www.schema.org/SiteNavigationElement"><li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-12125"><a href="https://www.northstarnm.com/radiopharmaceutical-therapy/">Radiopharmaceutical Therapy</a></li> <li class="menu-item menu-item-type-post_type menu-item-object-page current-menu-item page_item page-item-12595 current_page_item menu-item-12604"><a href="https://www.northstarnm.com/cdmo-cmo/" aria-current="page">CDMO/CMO</a></li> <li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-10982"><a href="https://www.northstarnm.com/development/">Development</a></li> <li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-10981"><a href="https://www.northstarnm.com/company/">Company</a></li> <li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-10980"><a href="https://www.northstarnm.com/careers/">Careers</a></li> <li class="searchlink menu-item menu-item-type-custom menu-item-object-custom menu-item-10984"><a href="#search"><i class="fas fa-search"></i> <span class="navhide">Search</span></a></li> </ul></div> </div> <div class="col-12 col-md-4 mb-4 mb-md-0 border-left px-md-4 py-md-2"> <div class="f-col-title"> HOW CAN WE HELP? </div> <div class="f-col-content"> <p>Questions about our company, products, supply solutions, careers or anything else?</p> </div> <div class="f-col-link"> <a href="https://www.northstarnm.com/company/contact-us/" target="" class="btn btn-wire">Contact Us</a> </div> <div class="inline-links"> <ul class="social-links"> <li><a href="https://www.linkedin.com/company/northstar-medical-radioisotopes-llc/" target="_blank" title=""><span class="social-text">LinkedIn</span><span class="fa-stack" style="vertical-align: top;"> <i class="fas fa-circle fa-stack-2x"></i> <i class="fab fa-linkedin-in fa-stack-1x fa-inverse"></i> </span></a></li> <li><a href="https://www.instagram.com/northstarmedicalradioisotopes/" target="_blank" title=""><span class="social-text">Instagram</span><span class="fa-stack" style="vertical-align: top;"> <i class="fas fa-circle fa-stack-2x"></i> <i class="fab fa-instagram fa-stack-1x fa-inverse"></i> </span></a></li> </ul> </div> </div> <div class="col-12 footer-copyright py-3 mb-5 white"> 漏<script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script><script>var CurrentYear = new Date().getFullYear(); document.write(CurrentYear);</script> NMR. 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