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Journal articles on the topic '68Ga generator'

Author: Grafiati

Published: 4 June 2021

Last updated: 16 June 2025

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1

Rösch, Frank. "68Ge/68Ga Generators and 68Ga Radiopharmaceutical Chemistry on Their Way into a New Century." Journal of Postgraduate Medicine, Education and Research 47, no. 1 (2013): 18–25. http://dx.doi.org/10.5005/jp-journals-10028-1052.

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ABSTRACT 68Ga faces a renaissance initiated by the development of new 68Ge/68Ga radionuclide generators, sophisticated 68Ga radiopharmaceuticals, preclinical research and state-of-the-art clincial diagnoses via positron emission tomography/computed tomography (PET/CT). A new type of 68Ge/68Ga generator became commercially available in the first years of the 21st century, with eluates based on hydrochloric acid. These generators provided ‘cationic’ 68Ga instead of ‘inert’ 68Gacomplexes, and opened new pathways of MeIII radiopharmaceutical chemistry. The last decade has seen a 68Ga rush. Increasing interest in generator-based 68Ga radiopharmaceuticals in diagnostic applications has been accompanied by its potential use in the context of diease treatment planning, made possible by the inherent option expressed by theranostics. However, widespread acceptance and clinical application requires optimization of 68Ge/68Ga generators both from chemical and regulatory perspectives. How to cite this article Rösch F. 68Ge/68Ga Generators and 68Ga Radiopharmaceutical Chemistry on Their Way into a New Century. J Postgrad Med Edu Res 2013;47(1):18-25.

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2

Sriprapa, Tossaporn, Thanete Doungta, Nopparath Sakulsamart, et al. "Evaluation of the Efficacy and Safety of the ITM 68Ge/68Ga Generator After its Recommended Shelf-life." Siriraj Medical Journal 75, no. 10 (2023): 752–58. http://dx.doi.org/10.33192/smj.v75i10.264289.

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Objective: 68Ga can be routinely produced by a 68Ge/68Ga generator without the need for a cyclotron. It is recommended to replace the 68Ge/68Ga generator after 250 elutions or 12 months of shelf-life whichever endpoint is reached first. However, a 68Ge/68Ga generator that has gone past its recommended lifespan can still be further used as a 68Ga source for 68Ga-labeled radiopharmaceuticals for use in animal experiments. To ensure the quality of 68Ga eluates, we aimed to evaluate the efficacy and safety of the ITM (Isotope Technologies München) 68Ge/68Ga generator in our institute after its recommended shelf-life. Materials and Methods: A 21-month-old ITM 68Ge/68Ga generator was eluted using 4.0 ml of 0.05 M HCl. The 68Ga elution yields were calculated, and 68Ge breakthrough was measured at least 48 h after elution in an aliquot amount using a multichannel analyzer (MCA) with a high-purity germanium probe. Metal impurities in the 68Ga eluates were analyzed by ICP-MS. Results: The elution yield of 68Ga was 35.2 ± 8.1%; n = 5 (decay corrected). 68Ge breakthrough from the ITM 68Ge/68Ga generator was below the detectable level. The average amounts of the metallic ions 57Fe, 66Zn, 203Pb, 60Ni, and 63Cu were 18.60, 9.86, 2.42, 0.52, and 0.47 µg/GBq, respectively. Conclusion: The ITM 68Ge/68Ga generator demonstrated consistent and reliable 68Ga elution profiles with an absence of either 68Ge breakthrough or other metal contaminants in the eluent samples as verified by the manufacturer. The use of the ITM 68Ge/68Ga generator could be extended past its recommended shelf-life to prepare 68Ga radiopharmaceuticals that are considered safe and suitable for use in animal experimentation and other applications.

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3

Lee, Jun-Young, Pyeong-Seok Choi, Seung-Dae Yang, and Jeong-Hoon Park. "TiO2 Decorated Low-Molecular Chitosan a Microsized Adsorbent for a 68Ge/68Ga Generator System." Molecules 26, no. 11 (2021): 3185. http://dx.doi.org/10.3390/molecules26113185.

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We report column material for a 68Ge/68Ga generator with acid resistance and excellent adsorption and desorption capacity of 68Ge and 68Ga, respectively. Despite being a core element of the 68Ge/68Ga generator system, research on this has been insufficient. Therefore, we synthesized a low molecular chitosan-based TiO2 (LC-TiO2) adsorbent via a physical trapping method as a durable 68Ge/68Ga generator column material. The adsorption/desorption studies exhibited a higher separation factor of 68Ge/68Ga in the concentration range of HCl examined (0.01 M to 1.0 M). The prepared LC-TiO2 adsorbent showed acid resistance capabilities with >93% of 68Ga elution yield and 1.6 × 10−4% of 68Ge breakthrough. In particular, the labeling efficiency of DOTA and NOTA, by using the generator eluted 68Ga, was quite encouraging and confirmed to be 99.65 and 99.69%, respectively. Accordingly, the resulting behavior of LC-TiO2 towards 68Ge/68Ga adsorption/desorption capacity and stability with aqueous HCl exhibited a high potential for ion-exchange solid-phase extraction for the 68Ge/68Ga generator column material.

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4

Baimukhanova, Ayagoz, Elena Chakrova, Dimitr Karaivanov, Jan Kozempel, Frank Roesch, and Dmitriy Filosofov. "Production of the positron-emitting radionuclide 68Ga: the radiochemical scheme of radionuclide generator 68Ge → 68Ga." Chemical Bulletin of Kazakh National University, no. 2 (June 30, 2018): 20–26. http://dx.doi.org/10.15328/cb1003.

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68Ga (T1 / 2 = 68 min) in complexes with peptides is used in positron emission tomography for diagnostics of neuroendocrine tumors. The most promising strategy for 68Ga production is usage of the radionuclide generator 68Ge → 68Ga. In this research, the sorption behavior of Ge(IV) and Ga (III) has been studied. The distribution coefficients (Kd) of Ge(IV) on the anion exchange (Dowex 1×8) and cation exchange (Dowex 50×8) resins in various ethanedioic and hydrochloric acid solutions were determined. For each ion exchange resin, four series of measurements were carried out, in which the concentration of oxalic acid was fixed (0.001 M, 0.003 M, 0.005 M, 0.01 M), and the concentrations of hydrochloric acid ranged from 0 to 3 M. Based on the distribution coefficients, the chemical scheme of the radionuclide generator 68Ge → 68Ga has been developed. The chemical system is based on the anion exchange resin Dowex 1×8 and mixture of 0.005 M C2H2O4 / 0.33 M HCl. Several types of the generators with direct and reverse mode of elution were tested and the optimal scheme was determined. Elution of the generators was performed once a day with 8 ml of 0.005 M C2H2O4 / 0.33 M HCl solution. The 68Ga yield and the 68Ge breakthrough are comparable for all the systems.

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5

Jaiuea, Phattarayut, Somlak Kongmuang, Kanyapat Lumyong, Thanete Doungta, and Shuichi Shiratori. "Optimization of the Use of the DOTATATE Kit Manufactured by the Thailand Institute of Nuclear Technology Using a SiO2-based 68Ge/68Ga Generator." Siriraj Medical Journal 76, no. 11 (2024): 789–96. http://dx.doi.org/10.33192/smj.v76i11.270157.

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Objective: The presence of somatostatin receptors on neuroendocrine tumours enables 68Ga-DOTATATE to precisely detect lesion localization and staging. Thailand Institute of Nuclear Technology (TINT) recently developed a DOTATATE kit for labelling with Ga-68, which is compatible with a TiO2-based 68Ge/68Ga generator eluted with 0.1 M HCl, but presents a discrepancy with other types of 68Ge/68Ga generators. This research aimed to optimize a radiolabelling method using TINT’s kit with a SiO2-based 68Ge/68Ga generator eluting Ga-68 in 0.05 M HCl. Additionally, a quality control protocol was developed to ensure the formulation’s efficacy and reliability in compliance with the 10th edition of the European Pharmacopoeia. Material and Methods: The SiO2-based 68Ge/68Ga generator was eluted with 2–4 ml of 0.05 M HCl, added into a lyophilized kit, heated in a dried-block heater at 100 ºC for 15 min, cooled down at room temperature, and finally purified using Sep-Pak C18 cartridge. The radiochemical purity was determined by radio thin-layer chromatography and the radioactivity was measured by a gamma well counter. Reproducibility and stability tests were conducted three times. Results: Employing 4 ml of eluted material, comprising the second and fifth millilitres of 68GaCl3, provided a radiochemical purity (RCP) exceeding 95% after purification. Also, 68Ga-DOTATATE remained stable in refrigerator for at least 4 half-lives. Conclusion: TINT’s DOTATATE kit can be successfully labelled with a SiO2-based 68Ge/68Ga generator, providing 68Ga-DOTATATE with an RCP > 95% for at least 4 half-lives when stored in refrigerator after production. This radiolabelling procedure is suitable for routine clinical application.

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6

Sriprapa, Tossaporn, Thanete Doungta, Napamon Sritongkul, and Malulee Tantawiroon. "Development of the Purification Process of Gallium-68 Eluted from Germanium-68/Gallium-68 Generator." Siriraj Medical Journal 76, no. 2 (2024): 90–96. http://dx.doi.org/10.33192/smj.v76i2.266113.

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Objective: 68Ga has a half-life of 68 minutes, with 89% of its decay is through positron emission. It is available from generator systems and possesses suitable property for labeling radioligands. These aspects make 68Ga a promising tracer for positron emission tomography (PET) imaging. This study aims to develop the purification process of the 68Ga eluates from 68Ge/68Ga generator after its recommended shelf-life and ensuring the quality through the radiolabeling process. Materials and Methods: In this study, we explored the development of a purification method for 68Ga eluted from a68Ge/68Ga generator before radiolabeling was investigated. Cation and anion exchange chromatography techniques were combined to remove trace amounts of competing metal ion impurities. Post-purification, the eluate’s metal contents were analyzed using inductively coupled plasma atomic emission spectroscopy (ICP-AES). Breakthrough of 68Ge was measured using a multi-channel analyzer (MCA) spectrometer with high-purity germanium (HPGe) radiation detectors. Additionally, the radiochemical purity of 68Ga-NOTA-RGD was analyzed by high-performance liquid chromatography (HPLC). Results: Metal impurities including Fe(II), Zn(II) and Al(III) were reduced by 61%, 38% and 44% respectively. The 68Ge breakthrough was approximately ~10–3%. The labeling efficiency with NOTA-RGD, a tracer for angiogenesis imaging, resulted in an average yield of 68Ga-NOTA-RGD (not corrected for decay) of around 50%, with aradiochemical purity by HPLC of approximately 98%–99%. Conclusion: Cation exchange in combination with anion exchange chromatography was thus proven to be an efficient method for purification of the 68Ga eluate from a 68Ge/68Ga generator prior to labeling the 68Ga PET radiotracer.

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7

Ambe, Shizuko. "68Ge68Ga generator with alpha-ferric oxide support." International Journal of Radiation Applications and Instrumentation. Part A. Applied Radiation and Isotopes 39, no. 1 (1988): 49–51. http://dx.doi.org/10.1016/0883-2889(88)90091-3.

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8

Schultz, Michael K., Patrick Donahue, Nannette I. Musgrave, et al. "An Increasing Role for 68Ga PET Imaging: A Perspective on the Availability of Parent 68Ge Material for Generator Manufacturing in an Expanding Market." Journal of Postgraduate Medicine, Education and Research 47, no. 1 (2013): 26–30. http://dx.doi.org/10.5005/jp-journals-10028-1053.

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ABSTRACT The use of gallium-68 for molecular imaging is gaining momentum world-wide. While our understanding of 68Ga chemistry, generators, and associated synthesis modules appear to have advanced to a clinically-reliable stage, uncertainty in the supply of radiopharmaceutically-suitable parent is of significant concern. In this work, we examine the current supply of 68Ge in an effort to better understand the potential for expansion of manufacturing to meet an increasing demand for 68Ga. Although specific information on sales and demand of 68Ge is highly business sensitive and thus guarded, our examination finds no shortage in the current supply of 68Ge. On the other hand, increases in the use of 68Ge generators for clinical applications in the United States point to the need for continued support for production at DOE laboratories in the United States to ensure a reliable supply and suggests that new commercial facilities may be needed to meet the increasing demand. How to cite this article Schultz MK, Donahue P, Musgrave NI, Zhernosekov K, Naidoo C, Razbash A, Tworovska I, Dick DW, Watkins GL, Graham MM, Runde W, Clanton JA, Sunderland JJ. An Increasing Role for 68Ga PET Imaging: A Perspective on the Availability of Parent 68Ge Material for Generator Manufacturing in an Expanding Market. J Postgrad Med Edu Res 2013;47(1):26-30.

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9

Feng, Yixiao, Yang Shao, Ziao Li, Min Luo, Diandou Xu, and Lingling Ma. "Research Progress on Major Medical Radionuclide Generators." Processes 13, no. 2 (2025): 521. https://doi.org/10.3390/pr13020521.

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As the concept of integrated diagnosis and treatment gains increasing prominence, the utilization of radiopharmaceuticals in personalized medicine has garnered unprecedented attention. However, the production of these radiopharmaceuticals continues to encounter numerous technical challenges. It plays an important role in improving the efficiency and convenience of nuclear medicine services and can quickly and conveniently provide the required radioactive isotopes to meet the needs of integrated clinical diagnosis and treatment while reducing dependence on external supplies and improving safety and the economy. At present, commonly used medical radioactive isotope generators include 99Mo/99mTc, 68Ge/68Ga, 90Sr/90Y, 188W/188Re, etc. This article reviews the latest research progress on three main medical radioactive isotope generators of 99Mo/99mTc, 68Ge/68Ga, and 90Sr/90Y. It also evaluates the highly anticipated new 44Ti/44Sc generator and proposes research prospects for current medical radioactive isotope generators, providing exploration directions for the future development of nuclear medicine.

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10

Gong, Xiang, Jiali Liu, and Sheng Hu. "Bayberry Tannin-modified SiO2 used for 68Ge/68Ga Generator." Academic Journal of Science and Technology 13, no. 3 (2024): 315–18. https://doi.org/10.54097/7wvzwe35.

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A synthetic method of modified SiO₂ grafted with bayberry tannin (SiO₂-BT) was reported. When the prepared SiO₂-BT was used for the treatment of the mixed solution of Ge and Ga, it could achieve a 99.99% Ge adsorption performance with hardly Ga adsorb. In addition, this SiO₂-BT also exhibited excellent acid resistance, in 0.1-0.5 M HCl solutions, it maintaining over 99.8% Ge adsorption efficiency. The results of radioactive experiments showed that with 10 μCi ⁶⁸Ge loaded, this SiO₂-BT could achieve an elution efficiency of ⁶⁸Ga of 75% while the breakthrough of ⁶⁸Ge maintained below 5×10-6. Overall, this SiO₂-BT has excellent acid resistance, highly efficient ⁶⁸Ga elution, and the characteristic of long-term low ⁶⁸Ge breakthrough, making it a potential adsorbent for ⁶⁸Ge/⁶⁸Ga generators.

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11

Roesch, Frank, and Patrick J. Riss. "The Renaissance of the 68Ge/68Ga Radionuclide Generator Initiates New Developments in 68Ga Radiopharmaceutical Chemistry." Current Topics in Medicinal Chemistry 10, no. 16 (2010): 1633–68. http://dx.doi.org/10.2174/156802610793176738.

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12

Rossouw, Daniel D., and Wouter A. P. Breeman. "Scaled-up radiolabelling of DOTATATE with 68Ga eluted from a SnO2-based 68Ge/68Ga generator." Applied Radiation and Isotopes 70, no. 1 (2012): 171–75. http://dx.doi.org/10.1016/j.apradiso.2011.07.016.

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13

Pandey, Usha, Aruna Korde, Archana Mukherjee, et al. "Clinical experience with indigenous kit-based preparation of 68Ga-DOTATOC using commercial 68Ge/68Ga generator." Applied Radiation and Isotopes 136 (June 2018): 59–64. http://dx.doi.org/10.1016/j.apradiso.2018.02.002.

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14

Kvaternik, Herbert, Elisabeth Plhak, Daniel Paul, Bernhard Rumpf, and Reingard Aigner. "68Ge/68Ga-generator: a radionuclide source or an approved drug?" Nuclear Medicine and Biology 96-97 (May 2021): S100. http://dx.doi.org/10.1016/s0969-8051(21)00432-7.

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15

Vyas, Chirag K., Jun Young Lee, Min Goo Hur, et al. "Chitosan-TiO2 composite: A potential 68Ge/68Ga generator column material." Applied Radiation and Isotopes 149 (July 2019): 206–13. http://dx.doi.org/10.1016/j.apradiso.2019.04.016.

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16

Asti, Mattia, Giovanni De Pietri, Alessandro Fraternali, et al. "Validation of 68Ge/68Ga generator processing by chemical purification for routine clinical application of 68Ga-DOTATOC." Nuclear Medicine and Biology 35, no. 6 (2008): 721–24. http://dx.doi.org/10.1016/j.nucmedbio.2008.04.006.

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17

Garcia, Victoria M., A. C. M. Silva, Rodrigo Modesto Gadelha Gontijo, and Andréa Vidal Ferreira. "Resolução espacial de um tomógrafo PET de pequenos animais usando o isótopo <sup>68</sup>Ga." Brazilian Journal of Radiation Sciences 12, no. 2 (2024): e2404. http://dx.doi.org/10.15392/2319-0612.2024.2404.

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Nuclear Medicine is a modality that has been growing a lot in Brazil and in the world, bringing new radiopharmaceuticals and technologies for the diagnosis and treatment of diseases, making them more effective and accurate. In the development of new radiopharmaceuticals for use in positron emission tomography (PET), the preclinical studies step largely uses PET scanners dedicated to small animals. To achieve this, quality control tests must be carried out to ensure the efficiency of the equipment. Thus, this work aimed to evaluate the spatial resolution of the small animals PET scanner of the CDTN using the isotope 68Ga. In this sense, a microPET hot rod phantom and a commercial 68Ge/68Ga generator were used to obtain PET images. The analysis of the 68Ga-PET images of the simulator was carried out qualitatively and quantitatively and revealed that the spatial resolution of the system using the 68Ga is 3.5 mm.

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18

Ovdiichuk, Olga, Emilie Roeder, Sébastien Billotte, Nicolas Veran, and Charlotte Collet. "Fully Automated Macro- and Microfluidic Production of [68Ga]Ga-Citrate on mAIO® and iMiDEVTM Modules." Molecules 27, no. 3 (2022): 994. http://dx.doi.org/10.3390/molecules27030994.

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68Ga-radionuclide has gained importance due to its availability via 68Ge/68Ga generator or cyclotron production, therefore increasing the number of 68Ga-based PET radiopharmaceuticals available in clinical practice. [68Ga]Ga-citrate PET has been shown to be prominent for detection of inflammation/infection of the musculoskeletal, gastrointestinal, respiratory, and cardiovascular systems. Automation and comparison between conventional and microfluidic production of [68Ga]Ga-citrate was performed using miniAllInOne® (Trasis) and iMiDEV™ (PMB-Alcen) synthetic modules. Fully automated procedures were elaborated for cGMP production of tracer. In order to facilitate the tracer approval as a radiopharmaceutical for clinical use, a new method for radiochemical identity determination by HPLC analysis to complement standard TLC radiochemical purity measurement was developed. The results showed higher radiochemical yields when using MCX cartridge on the conventional module mAIO®, while a PS-H+ cation exchanger was shown to be preferred for integration into the microfluidic cassette of iMiDEV™ module. In this study, the fully automated radiosynthesis of [68Ga]Ga-citrate using different synthesizers demonstrated reliable and reproducible radiochemical yields. In order to demonstrate the applicability of [68Ga]Ga-citrate, in vitro and in vivo studies were performed showing similar characteristics of the tracer obtained using macro- and microfluidic ways of production.

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19

Andronov, V. G., A. B. Bruskin, A. S. Sevast’yanova, G. E. Kodina, A. V. Ochkin, and G. V. Myasoedova. "Sorption conditioning of eluate of 68Ge/68Ga generator for medical purposes." Radiochemistry 50, no. 5 (2008): 535–40. http://dx.doi.org/10.1134/s1066362208050172.

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20

Petrik, Milos, Andrea Schuessele, Susanne Perkhofer, Cornelia Lass-Flörl, Dirk Becker, and Clemens Decristoforo. "Microbial challenge tests on nonradioactive TiO2-based 68Ge/68Ga generator columns." Nuclear Medicine Communications 33, no. 8 (2012): 819–23. http://dx.doi.org/10.1097/mnm.0b013e3283543323.

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21

Benhong, Cao, Li Zongquan, and Wang Yongxian. "68Ge−68Ga generator with alpha-ferric oxide support in trigonal structure." Journal of Radioanalytical and Nuclear Chemistry 238, no. 1-2 (1998): 175–78. http://dx.doi.org/10.1007/bf02385376.

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22

Casteleyn, K., R. Franceschini, F. Lunghi, et al. "Preparation of a 68Ge/68Ga generator for ionic gallium 68 production." Applied Radiation and Isotopes 45, no. 3 (1994): 395–96. http://dx.doi.org/10.1016/0969-8043(94)90083-3.

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23

Hörmann, Anton Amadeus, Gregor Schweighofer-Zwink, Gundula Rendl, et al. "[68Ga]Ga-FAP-2286—Synthesis, Quality Control and Comparison with [18F]FDG PET/CT in a Patient with Suspected Cholangiocellular Carcinoma." Pharmaceuticals 17, no. 9 (2024): 1141. http://dx.doi.org/10.3390/ph17091141.

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[68Ga]Ga-FAP-2286 is a new peptide-based radiopharmaceutical for positron-emission tomography (PET) that targets fibroblast activation protein (FAP). This article describes in detail the automated synthesis of [68Ga]Ga-FAP-2286 using a commercially available synthesis tool that includes quality control for routine clinical applications. The synthesis was performed using a Scintomics GRP-3V module and a GMP grade 68Ge/68Ga generator. A minor alteration for transferring the eluate to the module was established, eliminating the need for new method programming. Five batches of [68Ga]Ga-FAP-2286 were tested to validate the synthesis. A stability analysis was conducted up to 3 h after production to determine the shelf-life of the finished product. The automated synthesis on the Scintomics GRP-3V synthesis module was found to be compliant with all quality control requirements. The shelf-life of the product was set to 2 h post-production based on the stability study. A patient suffering from cholangiocellular carcinoma that could not be clearly detected by conventional imaging, including a [18F]FDG-PET/CT, highlights the potential use of [68Ga]Ga-FAP-PET/CT.

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24

Amor-Coarasa, A., M. Schoendorf, M. Meckel, S. Vallabhajosula, and J. W. Babich. "Comprehensive Quality Control of the ITG 68Ge/68Ga Generator and Synthesis of 68Ga-DOTATOC and 68Ga-PSMA-HBED-CC for Clinical Imaging." Journal of Nuclear Medicine 57, no. 9 (2016): 1402–5. http://dx.doi.org/10.2967/jnumed.115.171249.

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25

Vats, Kusum, Rohit Sharma, Haladhar D. Sarma, Drishty Satpati, and Ashutosh Dash. "68Ga-labeled HBED-CC Variant of uPAR Targeting Peptide AE105 Compared with 68Ga-NODAGA-AE105." Anti-Cancer Agents in Medicinal Chemistry 18, no. 9 (2019): 1289–94. http://dx.doi.org/10.2174/1871520618666180316152618.

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Aims: The urokinase Plasminogen Activator Receptors (uPAR) over-expressed on tumor cells and their invasive microenvironment are clinically significant molecular targets for cancer research. uPARexpressing cancerous lesions can be suitably identified and their progression can be monitored with radiolabeled uPAR targeted imaging probes. Hence this study aimed at preparing and evaluating two 68Ga-labeled AE105 peptide conjugates, 68Ga-NODAGA-AE105 and 68Ga-HBED-CC-AE105 as uPAR PET-probes. Method: The peptide conjugates, HBED-CC-AE105-NH2 and NODAGA-AE105-NH2 were manually synthesized by standard Fmoc solid phase strategy and subsequently radiolabeled with 68Ga eluted from a commercial 68Ge/68Ga generator. In vitro cell studies for the two radiotracers were performed with uPAR positive U87MG cells. Biodistribution studies were carried out in mouse xenografts with the subcutaneously induced U87MG tumor. Results: The two radiotracers, 68Ga-NODAGA-AE105 and 68Ga-HBED-CC-AE105 that were prepared in >95% radiochemical yield and >96% radiochemical purity, exhibited excellent in vitro stability. In vivo evaluation studies revealed higher uptake of 68Ga-HBED-CC-AE105 in U87MG tumor as compared to 68Ga-NODAGAAE105; however, increased lipophilicity of 68Ga-HBED-CC-AE105 resulted in slower clearance from blood and other non-target organs. The uPAR specificity of the two radiotracers was ascertained by significant (p<0.05) reduction in the tumor uptake with a co-injected blocking dose of unlabeled AE-105 peptide. Conclusion: Amongst the two radiotracers studied, the neutral 68Ga-NODAGA-AE105 with more hydrophilic chelator exhibited faster clearance from non-target organs. The conjugation of HBED-CC chelator (less hydrophilic) resulted in negatively charged 68Ga-HBED-CC-AE105 which was observed to have high retention in blood that decreased target to non-target ratios.

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26

Breeman, Wouter A. P., and Alfons M. Verbruggen. "The 68Ge/68Ga generator has high potential, but when can we use 68Ga-labelled tracers in clinical routine?" European Journal of Nuclear Medicine and Molecular Imaging 34, no. 7 (2007): 978–81. http://dx.doi.org/10.1007/s00259-007-0387-4.

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27

Таzhеdinov, I., Zh Аmankulov, U. K. Zhalmukash, Sh K. Hussain, and O. G. Hаn. "SOME PERSPECTIVE RADIONUCLIDES IN THE NUCLEAR MEDICINE OF KAZAKHSTAN." NNC RK Bulletin, no. 1 (March 30, 2018): 31–35. http://dx.doi.org/10.52676/1729-7885-2018-1-31-35.

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It is necessary to replenish the kit of the domestic generator 99mTc with new reagents, which expand the possibilities of radionuclide examination of organs and systems. It should be possible to release an ideal diagnostic pair for therapeutic radiopharmaceuticals, such as 123I for less affordable 131I. Establishing the production and cardiomyotropic and parathyroid tropic radiopharmaceutical 201Tl is important. Scintigraphy is one of the most informative imaging techniques. 68Ge/68Ga generator in accordance with the term of operation for two years, provides cancer specific pharmaceutical to oncological clinics, which is an alternative to expensive cyclotron radionuclides.

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28

Eppard, Elisabeth, Natalia S. Loktionova, and Frank Rösch. "68Ge content quality control of 68Ge/68Ga-generator eluates and 68Ga radiopharmaceuticals – A protocol for determining the 68Ge content using thin-layer chromatography." Applied Radiation and Isotopes 91 (September 2014): 92–96. http://dx.doi.org/10.1016/j.apradiso.2014.05.011.

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29

Chakravarty, Rubel, Rakesh Shukla, Ramu Ram, Avesh Kumar Tyagi, Ashutosh Dash, and Meera Venkatesh. "Development of a nano-zirconia based 68Ge/68Ga generator for biomedical applications." Nuclear Medicine and Biology 38, no. 4 (2011): 575–83. http://dx.doi.org/10.1016/j.nucmedbio.2010.10.007.

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30

Piras, Fabiano, Sartini, et al. "pH-Responsive Carboxymethylcellulose Nanoparticles for 68Ga-WBC Labeling in PET Imaging." Polymers 11, no. 10 (2019): 1615. http://dx.doi.org/10.3390/polym11101615.

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Carboxymethylcellulose (CMC) is a well-known pharmaceutical polymer, recently gaining attention in the field of nanomedicine, especially as a polyelectrolyte agent for the formation of complexes with oppositely charged macromolecules. Here, we report on the application of pH-sensitive pharmaceutical grade CMC-based nanoparticles (NP) for white blood cells (WBC) PET imaging. In this context and as an alternative to 99mTc-HMPAO SPECT labeling, the use of 68Ga3+ as PET radionuclide was investigated since, at early time points, it could provide the greater spatial resolution and patient convenience of PET tomography over SPECT clinical practices. Two operator-friendly kit-type formulations were compared, with the intention of radiolabeling within a short time (10 min), under mild conditions (physiological pH, room temperature) and in agreement with the actual clinically applied guidelines. NP were labeled by directly using 68Ga3+ eluted in HCL 0.05 N, from hospital suited 68Ge/68Ga generator and in absence of chelator. The first kit type approach involved the application of 68Ga3+ as an ionotropic gelation agent for in-situ forming NP. The second kit type approach concerned the re-hydration of a proper freeze-dried injectable NP powder. pH-sensitive NP with 250 nm average diameter and 80% labeling efficacy were obtained. The NP dispersant medium, including a cryoprotective agent, was modulated in order to optimize the Zeta potential value (−18 mV), minimize the NP interaction with serum proteins and guarantee a physiological environment for WBC during NP incubation. Time-dependent WBC radiolabeling was correlated to NP uptake by using both confocal and FT-IR microscopies. The ready to use lyophilized NP formulation approach appears promising as a straightforward 68Ga-WBC labeling tool for PET imaging applications.

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YAMASHITA, Masato, Hitoshi HORII, Yoshio IMAHORI, and Norihiko MIZUKAWA. "Elution test of an ionic 68Ga generator." RADIOISOTOPES 34, no. 12 (1985): 686–88. http://dx.doi.org/10.3769/radioisotopes.34.12_686.

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Bao, Borong, and Min Song. "A new68Ge/68Ga generator based on CeO2." Journal of Radioanalytical and Nuclear Chemistry Letters 213, no. 4 (1996): 233–38. http://dx.doi.org/10.1007/bf02163569.

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Ashhar, Zarif, Muhammad Fakhrurazi Ahmad Fadzil, Muhamad Faiz Othman, et al. "Cyclotron Production of Gallium-68 Radiopharmaceuticals Using the 68Zn(p,n)68Ga Reaction and Their Regulatory Aspects." Pharmaceutics 15, no. 1 (2022): 70. http://dx.doi.org/10.3390/pharmaceutics15010070.

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Designing and implementing various radionuclide production methods guarantees a sustainable supply, which is important for medical use. The use of medical cyclotrons for radiometal production can increase the availability of gallium-68 (68Ga) radiopharmaceuticals. Although generators have greatly influenced the demand for 68Ga radiopharmaceuticals, the use of medical cyclotrons is currently being explored. The resulting 68Ga production is several times higher than obtained from a generator. Moreover, the use of solid targets yields end of purification and end of synthesis (EOS) of up to 194 GBq and 72 GBq, respectively. Furthermore, experiments employing liquid targets have provided promising results, with an EOS of 3 GBq for [68Ga]Ga-PSMA-11. However, some processes can be further optimized, specifically purification, to achieve high 68Ga recovery and apparent molar activity. In the future, 68Ga will probably remain one of the most in-demand radionuclides; however, careful consideration is needed regarding how to reduce the production costs. Thus, this review aimed to discuss the production of 68Ga radiopharmaceuticals using Advanced Cyclotron Systems, Inc. (ACSI, Richmond, BC, Canada) Richmond, Canada and GE Healthcare, Wisconsin, USA cyclotrons, its related factors, and regulatory concerns.

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Tayal, Sachin, Murari Gurjar, Varun Shukla, Manikandan Marappagounder Venkatachalam, Rohit Kumar, and Yash Jain. "Time-efficient HPLC Validation Methodology for the Qualitative Analysis of 68Ga PSMA-11 in Routine Clinical Usage under Isocratic Method." Indian Journal of Nuclear Medicine 39, no. 4 (2024): 265–71. http://dx.doi.org/10.4103/ijnm.ijnm_42_24.

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Background: Prostate-specific membrane antigen (PSMA) has shown to be a promising agent for prostate cancer imaging under PET-CT. With the automation in radiolabeling with 68Ga, using iTG 68Ge/68Ga generator, it has helped introduce various new diagnostic agents and achieve good manufacturing practices (GMP) simultaneously. However, before any radiopharmaceutical is put into clinical usage, it should always be checked for its radiochemical purity and other quality parameters before injecting in the patient. Chromatography techniques such as Gas Chromatography (GC), High-Performance Liquid Chromatography (HPLC), and Thin-Layer Chromatography (TLC) are the most frequently utilized separation technique for purity analysis. A rapid quality control HPLC based methodology was required for radiopharmaceuticals. Aim & Objective: In our current setting, we conducted quality control analysis and standardized and validated HPLC method for the routine quality check of 68Ga-PSMA-11. Materials and Methods: The QC of 68Ga PSMA-11 was performed under ITLC and HPLC. Results: Linearity, accuracy, precision and specificity were assessed and quantified in accordance with International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (Q2 (R1) ICH) guidelines, which can be implemented in resource-limited settings to check the quality. Conclusion: The current HPLC based methodology is rapid, with a retention time of 2.24 min, rendering it a favorable analytical standard operating procedure for QC analysis of 68Ga-PSMA-11.

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Ghosh, Subhajit, Tapas Das, Shishu K. Suman, Haladhar D. Sarma, and Ashutosh Dash. "Preparation and Preliminary Evaluation of 68 Ga-Acridine: An Attempt to Study the Potential of Radiolabeled DNA Intercalator as a PET Radiotracer for Tumor Imaging." Anti-Cancer Agents in Medicinal Chemistry 20, no. 13 (2020): 1538–47. http://dx.doi.org/10.2174/1871520620666200502002609.

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Introduction: Acridine is a well-known DNA intercalator and thereby gets easily inserted within DNA. As uncontrolled rapid cell division is one of the primary characteristics of the tumors, it is expected that acridine or its suitable derivatives will have preferential accumulation in the tumorous lesions. Therefore, an attempt was made to radiolabel an acridine derivative with 68Ga and study the potential of the 68Ga-acridine complex as a PET agent for tumor imaging. Methods: 9-aminoacridine was coupled with p-NCS-benzyl-DOTA to render it suitable for labeling with 68Ga. The purified acridine-DOTA conjugate was radiolabeled with 68Ga, eluted from a 68Ge/68Ga radionuclide generator. Various radiolabeling parameters were optimized and the stability of the radiolabeled preparation was studied. The biological behavior of the 68Ga-acridine complex was studied both in vitro and in vivo using Raji cell line and fibrosarcoma tumor bearing Swiss mice, respectively. Results: 68Ga-acridine complex was obtained with ~100% radiochemical purity under the optimized reaction conditions involving incubation of 2mg/mL of ligand at 100°C for 30 minutes. The complex maintained a radiochemical purity of >95% in normal saline and >65% in human blood serum at 3h post-incubation. In vitro cellular study showed (3.2±0.1)% uptake of the radiotracer in the Raji cells. Biodistribution study revealed significant tumor accumulation [(11.41±0.41)% injected activity in per gram] of the radiotracer within 1h postadministration along with uptake in other non-target organs such as, blood, liver, GIT kidney etc. Conclusion: The present study indicates the potential of 68Ga-acridine as a PET agent for imaging of tumorous lesions. However, further detailed evaluation of the agent is warranted to explore its actual potential.

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Rangarajan, Venkatesh, Piyush Chandra, Bhakti Shetye, et al. "Initial clinical experience with 68Ga-DOTA-NOC prepared using 68Ga from nanoceria-polyacrylonitrile composite sorbent-based 68Ge/68Ga generator and freeze-dried DOTA-NOC kits." World Journal of Nuclear Medicine 16, no. 2 (2017): 140. http://dx.doi.org/10.4103/1450-1147.203072.

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de Blois, Erik, Ho Sze Chan, Clive Naidoo, Deidre Prince, Eric P. Krenning, and Wouter A. P. Breeman. "Characteristics of SnO2-based 68Ge/68Ga generator and aspects of radiolabelling DOTA-peptides." Applied Radiation and Isotopes 69, no. 2 (2011): 308–15. http://dx.doi.org/10.1016/j.apradiso.2010.11.015.

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Mundy, J., J. Zweit, B. Pratt, and A. Gilhespy-Muskett. "Development of an-in-house, low-cost 68Ge/68Ga generator for clinical PET." Nuclear Medicine Communications 16, no. 4 (1995): 246. http://dx.doi.org/10.1097/00006231-199504000-00133.

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Andreeff, M., G. Wunderlich, P. Wiggermann, K. Zöphel, and J. Kotzerke. "Ventilations-Perfusions-Lungen -szintigraphie mit der PET und 68Ga-markierten Radiopharmaka." Nuklearmedizin 49, no. 06 (2010): 203–8. http://dx.doi.org/10.3413/nukmed-0348-10-09.

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Summary Aim: Imaging of lung perfusion with positron emission tomography (PET) is already possible with 68Ga labeled denaturized albumin. The purpose of our study was to produce and test a 68Ga labeled aerosol (Galligas®) for ventilation and 68Ga labeled albumin particles (microspheres) for perfusion imaging with PET. Patients, methods: Galligas was produced by simmering and burning generator eluted 68Ga solution (100 MBq/0.1 ml) in an ordinary technegas generator. Fifteen patients with suspicion on pulmonary embolism underwent PET/CT (Biograph 16) after inhalation of Galligas and application of 68Ga labeled microspheres. A low dose CT was acquired for attenuation correction (AC). Images were reconstructed with and without AC. The inhaled activity was calculated compared to the activity injected. Results: Inhaled radioaerosol Galli gas demonstrated typical distribution as known from 99mTc-labeled technegas with homogeneous distribution in lung without hilar deposits. Attenuation corrected images resulted in artefacts in the lung base. Therefore, non-corrected images were used for making the results. Three out of fifteen patients showed a deficient perfusion whereas ventilation was normal corresponding to pulmonary embolism. Conclusion: Lung scintigraphy with PET is feasible. Galligas is simple to produce (analogously to technegas). 68Ga labeled microspheres are available. The method is applicable to daily routine and rendered clinically relevant informations.

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Viertl, D., S. Baechler, V. Dunet та ін. "68Ga-NODAGA-RGDyK for αvβ3 integrin PET imaging". Nuklearmedizin 50, № 06 (2011): 225–33. http://dx.doi.org/10.3413/nukmed-0416-11-06.

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Summary Aim: To visualize neovasculature and/or tumour integrin αvβ3 we selected the binding moiety Arg-Gly-Asp-D-Tyr-Lys (RGDyK) coupled to NODAGA for labeling with 68Ga. Methods: NODAGA-RGDyK (ABX) was labeled with the 68Ga eluate from the 68Ge generator IGG100 using the processor unit PharmTracer. Biodistribution was measured in female Hsd mice sacrificed 10, 30, 60 and 90 min after i. v. injection of 68Ga-NODAGA-RGDyK for OLINDA dosimetry extrapolated to humans. Tumour targeting was studied in SCID mice bearing A431 and other tumour transplants using microPET and biodistribution measurements. Results: Effective half-life of 68Ga-NODAGA-RGDyK was ∼25 min for total body and most organs except liver and spleen that showed stable activity retention. With a bladder voiding interval of 0.5 h the calculated effective dose (ED) was 0.012 and 0.016 mSv/MBq for males and females, respectively. Rapid uptake within 10 min was observed in A431 tumours with dynamic PET followed by a slow release. Biodistribution measurements showed a 68Ga-NODAGARGDyK uptake in A431 tumours of 3.4 ± 0.4 and 2.7 ±0.3%ID/g at 1 and 2 h, respectively. Similar uptakes were observed in a mouse and human breast and ovarian cancer xenografts. Co-injection of excess (5 mg/kg) unlabeled NODAGA- RGDyK with the radiotracer reduced tumour uptake at one hour to 0.23 ± 0.01%ID/g, but similarly decreased uptake in normal organs as well. When unlabeled peptide was injected 15 min after 68Ga- NODAGA- RGDyK, uptake diminished particularly in tumour and adrenals, suggestive of a different binding mode compared with other normal tissues. Conclusion: NODAGA- RGDyK was reliably labeled with 68Ga and revealed a predicted ED of 0.014 mSv/MBq. Tumour uptake was rapid and significant and was chased with unlabeled RGDyK in a similar manner as adrenal uptake.

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Gruber, Leonhard, Clemens Decristoforo, Christian Uprimny, et al. "Imaging Properties and Tumor Targeting of 68Ga-NeoBOMB1, a Gastrin-Releasing Peptide Receptor Antagonist, in GIST Patients." Biomedicines 10, no. 11 (2022): 2899. http://dx.doi.org/10.3390/biomedicines10112899.

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Background: Gastrin-releasing peptide receptors (GRPRs) are molecular imaging targets in multiple malignancies. Recently, NeoBOMB1, a 68Ga-labelled antagonist to GRPRs, was developed for PET. Here we report the outcome of a Phase I/IIa clinical trial (EudraCT 2016-002053-38) describing diagnostic properties and covariates influencing uptake of 68Ga-NeoBOMB1 in oligometastatic gastrointestinal stromal tumor (GIST) patients. Methods: Nine patients with advanced GIST using PET/CT (computed tomography) were included. After kit-based 68Ga-NeoBOMB1 preparation with a licensed 68Ge/68Ga generator, 3 MBq/kg body weight were injected intravenously. PET/CT included dynamic and static PET scans 5, 12 and 18 min and 1, 2, and 3–4 h post injection (first six patients) and static PET scans 2 and 3–4 h post injection (last three participants). Tumor targeting was assessed on a per-lesion and per-patient basis. Results: Six patients showed visible radiotracer uptake in at least one tumor lesion. Seventeen out of 37 tumor lesions exhibited significant 68Ga-NeoBOMB1 uptake (median SUVmax 11.8 [range 2.8–51.1] 2 h p.i. and 13.2 [range 2.5–53.8] 3–4 h p.i) and improved lesion-to-background contrast over time. Five lesions (13.5%) were identified only by 68Ga-NeoBOMB1-PET, with no correlation on contrast-enhanced CT. Three patients showed no radiotracer accumulation in any lesions. Tracer uptake correlated with male sex (p < 0.0001), higher body mass index (p = 0.007), and non-necrotic lesion appearance (p = 0.018). There was no association with whole-lesion contrast enhancement, hepatic localization, mutational status, or disease duration. Conclusions: 68Ga-NeoBOMB1-PET exhibits variable tumor uptake in advanced-stage GIST patients, correlating with lesion vitality based on CT contrast uptake, opening the possibility of a theragnostic approach in selected cases.

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Zhernosekov, K. P., D. V. Filosofov, R. P. Baum, et al. "Processing of Generator-Produced 68Ga for Medical Application." Journal of Nuclear Medicine 48, no. 10 (2007): 1741–48. http://dx.doi.org/10.2967/jnumed.107.040378.

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Kraihammer, Martin, Miloš Petřík, Christine Rangger, et al. "Automated Production of [68Ga]Ga-Desferrioxamine B on Two Different Synthesis Platforms." Pharmaceutics 16, no. 9 (2024): 1231. http://dx.doi.org/10.3390/pharmaceutics16091231.

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Background/Objectives: PET imaging of bacterial infection could potentially provide added benefits for patient care through non-invasive means. [68Ga]Ga-desferrioxamine B—a radiolabelled siderophore—shows specific uptake by human-pathogenic bacteria like Staphylococcus aureus or Pseudomonas aeruginosa and sufficient serum stability for clinical application. In this report, we present data for automated production of [68Ga]Ga-desferrioxamine B on two different cassette-based synthesis modules (Modular-Lab PharmTracer and GRP 3V) utilising commercially obtainable cassettes together with a licensed 68Ge/68Ga radionuclide generator. Methods: Quality control, including the determination of radiochemical purity, as well as a system suitability test, was set up via RP-HPLC on a C18 column. The two described production processes use an acetic acid/acetate buffer system with ascorbic acid as a radical scavenger for radiolabelling, yielding ready-to-use formulations with sufficient activity yield. Results: Batch data analysis demonstrated radiochemical purity of >95% by RP-HPLC combined with ITLC and excellent stability up to 2 h after synthesis. Specifications for routine production were set up and validated with four masterbatches for each synthesis module. Conclusions: Based on this study, an academic clinical trial for imaging of bacterial infection was initiated. Both described synthesis methods enable automated production of [68Ga]Ga-desferrioxamine B in-house with high reproducibility for clinical application.

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Chakravarty, Rubel, Sudipta Chakraborty, Rakesh Shukla, et al. "Mechanochemical synthesis of mesoporous tin oxide: a new generation nanosorbent for 68Ge/68Ga generator technology." Dalton Transactions 45, no. 34 (2016): 13361–72. http://dx.doi.org/10.1039/c6dt01921h.

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45

Nanabala, Raviteja, Muhammed K. Anees, Arun Sasikumar, Ajith Joy, and M. R. A. Pillai. "Preparation of [68Ga]PSMA-11 for PET–CT imaging using a manual synthesis module and organic matrix based 68Ge/68Ga generator." Nuclear Medicine and Biology 43, no. 8 (2016): 463–69. http://dx.doi.org/10.1016/j.nucmedbio.2016.05.006.

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Lee, Jun Young, Chirag K. Vyas, Bo-Ram Kim, et al. "Acid resistant zirconium phosphate for the long term application of 68Ge/68Ga generator system." Applied Radiation and Isotopes 118 (December 2016): 343–49. http://dx.doi.org/10.1016/j.apradiso.2016.09.025.

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47

Wagner, Michael, Johan G. Doverfjord, Joachim Tillner, et al. "Automated GMP-Compliant Production of [68Ga]Ga-DO3A-Tuna-2 for PET Microdosing Studies of the Glucagon Receptor in Humans." Pharmaceuticals 13, no. 8 (2020): 176. http://dx.doi.org/10.3390/ph13080176.

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Introduction: [68Ga]Ga-DO3A-VS-Cys40-Tuna-2 (previously published as [68Ga]Ga-DO3A-VS-Cys40-S01-GCG) has shown high-affinity specific binding to the glucagon receptor (GCGR) in vitro and in vivo in rats and non-human primates in our previous studies, confirming the suitability of the tracer for drug development applications in humans. The manufacturing process of [68Ga]Ga-DO3A-VS-Cys40-Tuna-2 was automated for clinical use to meet the radiation safety and good manufacturing practice (GMP) requirements. Methods: The automated synthesis platform (Modular-Lab PharmTrace, Eckert & Ziegler, Eurotope, Germany), disposable cassettes for 68Ga-labeling, and pharmaceutical-grade 68Ge/68Ga generator (GalliaPharm®) used in the study were purchased from Eckert & Ziegler. The parameters such as time, temperature, precursor concentration, radical scavenger, buffer concentration, and pH, as well as product purification step, were investigated and optimized. Process optimization was conducted with regard to product quality and quantity, as well as process reproducibility. The active pharmaceutical ingredient starting material DO3A-VS-Cys40-Tuna-2 (GMP-grade) was provided by Sanofi Aventis. Results: The reproducible and GMP-compliant automated production of [68Ga]Ga-DO3A-VS-Cys40-Tuna-2 with on-line documentation was developed. The non-decay-corrected radiochemical yield was 45.2 ± 2.5% (n = 3, process validation) at the end of the synthesis with a labeling synthesis duration of 38 min and a quality controlincluding release procedure of 20 min. The radiochemical purity of the product was 98.9 ± 0.6% (n = 17) with the total amount of the peptide in the preparation of 48 ± 2 µg (n = 3, process validation). Radionuclidic purity, sterility, endotoxin content, residual solvent content, and sterile filter integrity tests met the acceptance criteria. The product was stable at ambient temperature for at least 2 h. Conclusion: The fully automated GMP-compliant manufacturing process was developed and thoroughly validated. The resulting [68Ga]Ga-DO3A-VS-Cys40-Tuna-2 was used in a clinical study for accurate quantification of GCGR occupancy by a dual anti-diabetic drug in vivo in humans.

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Eppard, E., M. Wuttke, P. L. Nicodemus, and F. Rosch. "Ethanol-Based Post-processing of Generator-Derived 68Ga Toward Kit-Type Preparation of 68Ga-Radiopharmaceuticals." Journal of Nuclear Medicine 55, no. 6 (2014): 1023–28. http://dx.doi.org/10.2967/jnumed.113.133041.

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Petrik, M., M. Ocak, M. Rupprich, and C. Decristoforo. "Impurity in 68Ga-Peptide Preparation Using Processed Generator Eluate." Journal of Nuclear Medicine 51, no. 3 (2010): 495. http://dx.doi.org/10.2967/jnumed.109.070953.

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50

Lu, Yingqing, Philip H. Chao, Jeffrey Collins, and R. Michael van Dam. "Rapid Concentration of Ga-68 and Proof-of-Concept Microscale Labeling of [68Ga]Ga-PSMA-11 in a Droplet Reactor." Molecules 29, no. 19 (2024): 4572. http://dx.doi.org/10.3390/molecules29194572.

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The radiometal gallium-68 (Ga-68) has garnered significant interest due to its convenient production via compact and widely available generators and the high performance of 68Ga-labeled compounds for positron-emission tomography (PET) imaging for cancer diagnosis and management of patients undergoing targeted radionuclide therapy. Given the short half life of Ga-68 (68 min), microfluidic-based radiosynthesis is a promising avenue to establish very rapid, efficient, and routine radiolabeling with Ga-68; however, the typical elution volume of Ga-68 from a generator (4–10 mL) is incompatible with the microliter reaction volumes of microfluidic devices. To bridge this gap, we developed a microscale cartridge-based approach to concentrate Ga-68. By optimizing cartridge design, resin type, resin mass, and eluent composition, Ga-68 was reliably concentrated from ~6 mL to ~80 µL with high recovery efficiency (>97%, n = 14). Furthermore, this method is suitable for both single- and dual-generator setups. To demonstrate suitability of the concentrated radiometal for radiolabeling, we performed microdroplet synthesis of [68Ga]Ga-PSMA-11, achieving high radiochemical yield (83 ± 11%, n = 3), excellent radiochemical purity (>99%), and high apparent specific activity (255–320 MBq/μg). The entire process, including Ga-68 concentration, radiosynthesis, purification, and formulation, was completed in 12 min. Starting with activity of 0.81–0.84 GBq, 0.51–0.64 GBq of product was produced, sufficient for multiple patient doses. This work paves the way to clinical-scale production of other 68Ga-labeled compounds using droplet microreactor methods, or high-throughput labeling optimization or compound screening of 68Ga-labeled probes using droplet reaction arrays.

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