Planning and Management of Radiopharmaceutical Development Processes Using Technology Readiness Level Scale

INTRODUCTION . The demand for new diagnostic and treatment solutions using radiopharmaceuticals (RPs), along with the growing nuclear medicine market, drives active development and rapid introduction of innovative RPs into circulation. These products possess a complex multi-component structure and specific radioactivity, a feature to be taken into account when planning and controlling research during drug development and subsequent technology transfer. AIM . This study aimed to optimise RP development process using Technology Readiness Level (TRL) scale. DISCUSSION . The authors analysed application of an industry-specific TRL scale for RPs. This scale considers key points for RPs: isotope content and biological molecules in the compound; necessity of quality control for specific parameters such as radiochemical purity, stability, and biological activity, as well as market circulation specifics. Correctly choosing intended use and marketing option of a developed RP is critically important, as this defines not only registration strategy but also quality requirements for the resulting product. Experience of JSC “Rosatom Science” has highlighted potential key risks, such as equipment contamination, radioactive decay rate during logistics, and other parameters. The key points in applying the scale to generic RPs were also high-lighted: the first four stages of the scale accelerated; necessity to select an original target molecule, as well as design differences of preclinical and clinical trials to obtain convincing evidence of generic bioequivalence to the reference product. CONCLUSIONS . The adapted TRL scale for RPs is a validated tool that enables a comprehensive control over key development stages, timely risk identification and mitigation. The scale contributes to accelerating market introduction of innovative and generic RPs through transparent and stepwise planning, standard process monitoring, and use of the full development cycle, including marketing strategy.