Frequently Asked Questions (FAQs)

With nearly 15 years of experience in manufacturing radiopharmaceutical products, we have manufactured 1,000+ cGMP batches, shipped 4,400+ cGMP doses, supported 70+ clinical development and tech transfer programs across Phase I–III, and achieved a 99% delivery success rate across 28 countries. We have also successfully filed more than 525 regulatory submissions to Health Canada and the FDA with >99% success rate.

We support radiopharmaceutical development from early-stage process development through clinical production for phases I to III, and commercial manufacturing. Our integrated services include process and analytical method development, tech transfer, optimization, scale-up studies, process and analytical method qualification and/or validation, cGMP manufacturing, quality and compliance, regulatory support, logistics, and global distribution.

Pre-Trial Activities

• Development, tech transfer & optimization of analytical methods & radiolabeling processes as well as stability studies
• Phase-appropriate Qualification and/or Validation of analytical methods & radiolabeling processes
• Scale-up Studies to support early to late clinical phase studies
• Experience in working with Lu-177, Ac-225, In-111, I-131, Y-90 & more
• Expertise in working with small molecules, peptides & antibodies
• Consultation on CMC strategy, leveraging AtomVie’s expertise in analytical method and radiolabeling process development.

Trial Planning

• Regulatory affairs: CTA/IND filing & amendments
• Experienced with Health Canada & FDA, with more jurisdictions to be included
• Support sites doing Research Ethics Board Submissions
• Consultation on regulatory strategies and preparation for regulatory agency meetings

Trial Execution

• cGMP manufacturing for clinical supply (phases I to III)
• Logistics & global distribution
• Quality & compliance
• Scale-up processes

Market Entry

• Commercial manufacturing

Yes. AtomVie is built to support partners from early development through early to late clinical trials and into commercial manufacturing. This lifecycle approach helps sponsors avoid disruptive CDMO transitions, preserve process knowledge, and maintain continuity as programs advance from Phase I through late-stage development and commercialization.

Our new Hamilton facility is purpose-built for lifecycle radiopharmaceutical development and manufacturing, with infrastructure designed to support low-, mid-, and high-throughput production. The facility expands our total capacity with 72,300 square feet of space, the largest single site in North America to date, with more than 18 production lines, a development suite, QC and micro labs, material storage, waste management, packaging & shipping areas, and flexible space for your needs.

We possess rich experience working with small molecules, peptides, small antibodies, and large antibodies. This breadth of experience allows our experts to support a range of next-generation radiotherapeutic, diagnostic and theranostic programs across development, manufacturing, and commercialization.

We’ve successfully delivered radiopharmaceutical doses to 28 countries across North America, Europe, Asia, Australia, Africa, and South America. Our new Hamilton site is strategically located near the Hamilton International Airport, with easy access to Pearson International Airport and the U.S. border, supporting time-sensitive global shipment needs.

Yes. We support multiple regulatory activities including, but not limited to, CTA/IND filing and amendments, with experience working with Health Canada and the FDA. Our team has also completed more than 525 regulatory submissions to both entities, with >99% success rate.

Yes. AtomVie can work with all isotopes & multiple types of precursors including small molecules, peptides and antibodies. While we focus on long-lived isotopes, as they align well with our current business model and established supply chain, we also execute programs with long-lived diagnostic isotopes, such as In-111, Zr-89 and more. We have a strategic partnership and supply agreements with TPI and Ionetix Ac-225 suppliers, which will provide added value to our clients with Ac-225-based clinical programs. For Lu-177, we have a portfolio of qualified vendors in-house as well as a supply agreement with E&Z, allowing us to collaborate with multiple Lu-177 sources to meet our clients’ needs.