Radiolabeling Services

RTI provides high-level radiochemistry expertise and full-service radiosynthesis laboratory capabilities without the administrative layers or inflated overhead of large CMOs. By applying a nimble, sound, scientific approach, such as utilizing a compliant dilution and crystallization strategy for human ¹⁴C AME studies, which meets all FDA requirements, RTI offers a pathway for clients to secure radiolabeled compounds efficiently and cost-effectively for all radiolabeled studies that are required for an NDA submission.

Radiolabeled compounds are also required for New Drug Application (NDA) and Investigational New Drug (IND) applications to the Food and Drug Administration. Compounds labeled with ³H or ¹⁴C generate the precise, decision-enabling data on drug metabolism, tissue distribution, and pharmacokinetics that the FDA demands. RTI provides custom synthesis, analytical purification, and regulatory support tailored to the specific milestone of each drug candidate:

RTI’s radiochemists bring decades of combined experience to the lab. Our in-house problem-solving has proven critical for clients facing challenging or first-time isotopic label placements. We also follow a sequential workflow that encompasses label position confirmation, cold non-radioactive validation runs, optional tracer runs, and hot synthesis. Together, our expertise and approach enable faster turnaround times than those of larger, less nimble CMOs. 

We perform preparative HPLC and flash chromatography purification in keycard-access-restricted hot labs equipped with tritium gas manifolds, vacuum lines and inert atmosphere handling capability. Additionally, every deliverable includes identity, radiochemical purity, chemical purity, and specific activity data backed by a Certificate of Analysis (CoA), analytical raw data and for a ¹⁴C human AME study, a TSEBSE statement and a stability report is provided. 

Proven Track Record in Radiolabeling Services 

Since 2023 alone, RTI has successfully executed over 130 custom radiolabeling projects. RTI maintains long-standing collaborative partnerships with global CRO leaders, serving as their dedicated radiochemistry engine to synthesize labeled compounds for preclinical and clinical studies. 

Practical, FDA-Compliant Regulatory Approach 

Rather than imposing unnecessary, expensive GMP protocols, RTI uses a scientifically sound dilution and crystallization approach to produce ¹⁴C supplies for human AME studies. This flexible methodology meets all US FDA regulatory requirements for conducting human ¹⁴C AME studies while significantly reducing costs and turnaround times for sponsors. 

Nimble, Scalable Operations 

RTI combines a full-service, secure radiochemistry facility with a lean, highly responsive operating model. With single-point technical accountability and the ability to seamlessly scale team capacity as project demands expand, clients receive rapid communication and execution without paying for unnecessary CMO overhead.