Nader_2022_Nucl.Med.Biol_110-111_37

INTRODUCTION: With respect to the broad application of FAPI-46 in therapy and diagnostics, there is a need for an efficient as well as convenient way for routine production and quality control of the theranostic pair [(90)Y]Y/[(68)Ga]Ga-FAPI-46, since no monograph is currently available for radiolabelled FAPI derivatives. The aim of the current work is to create a GMP compliant theranostic set up for the production and quality control of the diagnostic [(68)Ga]Ga-FAPI-46 as well as the therapeutic drug [90 Y]Y-FAPI-46, which can be the basis for future monographic standards. METHODS: Sterile [(90)Y]yttrium chloride solution and a pharmaceutical grade (68)Ge/(68)Ga generator were applied for the labelling of FAPI-46 using the cassette based synthesis module Trasis EASYONE. All chemicals were GMP-grade and excipients were with marketing authorisation. The quality control included test procedures according to Ph. Eur. RESULTS: Fully automated synthesis of the theranostic pair [(90)Y]Y/[(68)Ga]Ga-FAPI-46 was achieved on the Trasis EasyOne synthesizer with a radiochemical yield of 88 +/- 7% and 56 +/- 5% with a radiochemical purity of >99%. Stability experiments showed a durability for [(68)Ga]Ga-FAPI-46 within 4 h and for [(90)Y]Y-FAPI-46 within 24 h. All obtained specifications and validations were compliant with the European Pharmacopoeia and regulatory guidelines. Both products were successfully applied in cancer patients. CONCLUSION: In the present work, efficient and robust procedures for the automated production and quality control of the theranostic pair [(68)Ga]/[(90)Y]FAPI 46 were developed and validated using the same synthetic platform. The described methods were evaluated in accordance with existing guidelines and toxicological limits, which can be a valuable basis for future monographic standards.