Radiosynthesis of a Novel PET Fluoronicotinamide for Melanoma Tumour PET Imaging; [18F]MEL050

2011 ◽  
Vol 64 (7) ◽  
pp. 873 ◽  
Author(s):  
Ivan Greguric ◽  
Stephen Taylor ◽  
Tien Pham ◽  
Naomi Wyatt ◽  
Cathy D. Jiang ◽  
...  
Keyword(s):  
Total Synthesis ◽  
Large Scale ◽  
Radiochemical Purity ◽  
Specific Activity ◽  
Phase 1 ◽  
Radiochemical Yield ◽  
Synthesis Time ◽  
Clinical Phase ◽  
One Step ◽  
No Carrier Added

[18F]6-Fluoro-N-[2-(diethylamino)ethyl]nicotinamide [18F]MEL050 is a novel nicotinamide-based radiotracer, designed to target random metastatic dissemination of melanoma tumours by targeting melanin. Preclinical studies suggest that [18F]MEL050 has an excellent potential to improve diagnosis and staging of melanoma. Here we report the radiochemical optimization conditions of [18F]MEL050 and its large scale automated synthesis using a GE FXFN automated radiosynthesis module for clinical, phase-1 investigation. [18F]MEL050 was prepared via a one-step synthesis using no-carrier added K[18F]F-Krytpofix® 222 (DMSO, 170°C, 5 min) followed by HPLC purification. Using 6-chloro-N-[2-(diethylamino)ethyl]nicotinamide as precursor, [18F]MEL050 was obtained in 40–46% radiochemical yield (non-decay corrected), in greater than 99.9% radiochemical purity and specific activity ranging from 240 to 325 GBq μmol–1. Total synthesis time including formulation was 40 min and [18F]MEL050 was stable (99.8%) in PBS for 6 h.

scholarly journals One-Step Synthesis of N-Succinimidyl-4-[18F]Fluorobenzoate ([18F]SFB)

Molecules ◽  
2019 ◽  
Vol 24 (19) ◽  
pp. 3436 ◽  
Author(s):  
Ida Nymann Petersen ◽  
Jacob Madsen ◽  
Christian Bernard Matthijs Poulie ◽  
Andreas Kjær ◽  
Matthias Manfred Herth
Keyword(s):  
Solid Phase Extraction ◽  
Total Synthesis ◽  
Radiochemical Purity ◽  
Solid Phase ◽  
Phase Extraction ◽  
One Pot ◽  
Synthesis Time ◽  
Synthesis Route ◽  
One Step

Herein, we present a one-step labeling procedure of N-succinimidyl-4-[18F]-fluorobenzoate ([18F]SFB) starting from spirocyclic iodonium ylide precursors. Precursor syntheses succeeded via a simple one-pot, two-step synthesis sequence, in yields of approximately 25%. Subsequent 18F-nucleophilic aromatic labeling was performed, and radiochemical incorporations (RCCs) from 5–35% were observed. Purification could be carried out using HPLC and subsequent solid phase extraction. Radiochemical purity (RCP) of >95% was determined. The total synthesis time, including purification and formulation, was no longer than 60 min. In comparison to the established 3-step synthesis route of [18F]SFB, this one-step approach avoids formation of volatile radioactive side-products and simplifies automatization.

scholarly journals Development of [225Ac]Ac-PSMA-I&T for Targeted Alpha Therapy According to GMP Guidelines for Treatment of mCRPC

Pharmaceutics ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 715
Author(s):  
Eline L. Hooijman ◽  
Yozlem Chalashkan ◽  
Sui Wai Ling ◽  
Figen F. Kahyargil ◽  
Marcel Segbers ◽  
...  
Keyword(s):  
Dose Escalation ◽  
Radiochemical Purity ◽  
Phase 1 ◽  
Radiochemical Yield ◽  
Good Manufacturing Practice ◽  
Castration Resistant Prostate Cancer ◽  
Antitumor Effects ◽  
Dose Escalation Study ◽  
Clinical Phase ◽  
Alpha Emitter

Recently, promising results of the antitumor effects were observed in patients with metastatic castration-resistant prostate cancer treated with 177Lu-labeled PSMA-ligands. Radionuclide therapy efficacy may even be improved by using the alpha emitter Ac-225. Higher efficacy is claimed due to high linear energy transfer specifically towards PSMA positive cells, causing more double-strand breaks. This study aims to manufacture [225Ac]Ac-PSMA-I&T according to good manufacturing practice guidelines for the translation of [225Ac]Ac-PSMA-I&T into a clinical phase 1 dose escalation study. Quencher addition during labeling was investigated. Quality control of [225Ac]Ac-PSMA-I&T was based on measurement of Fr-221 (218 keV), in equilibrium with Ac-225 in approximately six half-lives of Fr-221 (T½ = 4.8 min). Radio-(i)TLC methods were utilized for identification of the different radiochemical forms, gamma counter for concentration determination, and HPGe-detector for the detection of the radiochemical yield. Radiochemical purity was determined by HPLC. The final patient dose was prepared and diluted with an optimized concentration of quenchers as during labeling, with an activity of 8–12 MBq (±5%), pH > 5.5, 100 ± 20 μg/dose, PSMA-I&T, radiochemical yield >95%, radiochemical purity >90% (up to 3 h), endotoxin levels of <5 EU/mL, osmolarity of 2100 mOsmol, and is produced according to current guidelines. The start of the phase I dose escalation study is planned in the near future.

scholarly journals Robust and Facile Automated Radiosynthesis of [18F]FSPG on the GE FASTlab

2020 ◽  
Author(s):  
Richard Edwards ◽  
Hannah Greenwood ◽  
Timothy Witney
Keyword(s):  
Large Scale ◽  
Radiochemical Purity ◽  
Radiochemical Yield ◽  
Reaction Conditions ◽  
Positron Emission ◽  
Optimized Protocol ◽  
Cancer Types ◽  
Automated Procedures ◽  
Phosphate Buffered Saline ◽  
High Radioactivity

<p><i>Purpose</i>: (S)-4-(3-<sup>18</sup>F-Fluoropropyl)-ʟ-Glutamic Acid ([<sup>18</sup>F]FSPG) is a radiolabeled non-natural amino acid that is used for positron emission tomography (PET) imaging of the glutamate/cystine antiporter, system x<sub>C</sub><sup>-</sup>, whose expression is upregulated in many cancer types. To increase the clinical adoption of this radiotracer, reliable and facile automated procedures for [<sup>18</sup>F]FSPG production are required. Here, we report a cassette-based method to produce [<sup>18</sup>F]FSPG at high radioactivity concentrations from low amounts of starting activity.</p><p><i>Procedures</i>: An automated synthesis and purification of [<sup>18</sup>F]FSPG was developed for the GE FASTlab. Optimization of the reaction conditions and automated manipulations were performed by measuring the isolated radiochemical yield of [<sup>18</sup>F]FSPG and by assessing radiochemical purity using radioHPLC. Purification of [<sup>18</sup>F]FSPG was conducted by trapping and washing of the radiotracer on MCX SepPak catridges, followed by a reverse elution of [<sup>18</sup>F]FSPG in phosphate-buffered saline. Subsequently, the [<sup>18</sup>F]FSPG obtained from the optimized process was used to image an animal model of non-small cell lung cancer.</p><p><i>Results</i>: The optimized protocol produced [<sup>18</sup>F]FSPG in 38.4 ± 2.6% RCY and 96% radiochemical purity. Small alterations, including the implementation of a reverse elution and an altered hypercarb cartridge, lead to significant improvements in radiotracer concentration from <10 MBq/mL to >100 MBq/mL. The improved radiotracer concentration allowed for the imaging of up to 20 mice, starting with just 1.5 GBq of [<sup>18</sup>F]fluoride.</p><p><i>Conclusions: </i>We have developed a robust and facile method for [<sup>18</sup>F]FSPG radiosynthesis in high radiotracer concentration, RCP and RCY. This cassette-based method enabled the production of [<sup>18</sup>F]FSPG at radioactive concentrations sufficient to facilitate large-scale preclinical experiments with a single prep of starting activity. The use of cassettes for an ‘out the box’ synthesis on a synthesis module routinely used for clinical production make the method amenable to rapid and widespread clinical translation.</p>

scholarly journals Robust and Facile Automated Radiosynthesis of [18F]FSPG on the GE FASTlab

2020 ◽  
Author(s):  
Richard Edwards ◽  
Hannah Greenwood ◽  
Timothy Witney
Keyword(s):  
Large Scale ◽  
Radiochemical Purity ◽  
Radiochemical Yield ◽  
Reaction Conditions ◽  
Positron Emission ◽  
Optimized Protocol ◽  
Cancer Types ◽  
Automated Procedures ◽  
Phosphate Buffered Saline ◽  
High Radioactivity

<p><i>Purpose</i>: (S)-4-(3-<sup>18</sup>F-Fluoropropyl)-ʟ-Glutamic Acid ([<sup>18</sup>F]FSPG) is a radiolabeled non-natural amino acid that is used for positron emission tomography (PET) imaging of the glutamate/cystine antiporter, system x<sub>C</sub><sup>-</sup>, whose expression is upregulated in many cancer types. To increase the clinical adoption of this radiotracer, reliable and facile automated procedures for [<sup>18</sup>F]FSPG production are required. Here, we report a cassette-based method to produce [<sup>18</sup>F]FSPG at high radioactivity concentrations from low amounts of starting activity.</p><p><i>Procedures</i>: An automated synthesis and purification of [<sup>18</sup>F]FSPG was developed for the GE FASTlab. Optimization of the reaction conditions and automated manipulations were performed by measuring the isolated radiochemical yield of [<sup>18</sup>F]FSPG and by assessing radiochemical purity using radioHPLC. Purification of [<sup>18</sup>F]FSPG was conducted by trapping and washing of the radiotracer on MCX SepPak catridges, followed by a reverse elution of [<sup>18</sup>F]FSPG in phosphate-buffered saline. Subsequently, the [<sup>18</sup>F]FSPG obtained from the optimized process was used to image an animal model of non-small cell lung cancer.</p><p><i>Results</i>: The optimized protocol produced [<sup>18</sup>F]FSPG in 38.4 ± 2.6% RCY and 96% radiochemical purity. Small alterations, including the implementation of a reverse elution and an altered hypercarb cartridge, lead to significant improvements in radiotracer concentration from <10 MBq/mL to >100 MBq/mL. The improved radiotracer concentration allowed for the imaging of up to 20 mice, starting with just 1.5 GBq of [<sup>18</sup>F]fluoride.</p><p><i>Conclusions: </i>We have developed a robust and facile method for [<sup>18</sup>F]FSPG radiosynthesis in high radiotracer concentration, RCP and RCY. This cassette-based method enabled the production of [<sup>18</sup>F]FSPG at radioactive concentrations sufficient to facilitate large-scale preclinical experiments with a single prep of starting activity. The use of cassettes for an ‘out the box’ synthesis on a synthesis module routinely used for clinical production make the method amenable to rapid and widespread clinical translation.</p>

Synthesis of 18F-labelled 2-fluoroethyl-nitrosoureas

1984 ◽  
Vol 62 (11) ◽  
pp. 2107-2112 ◽  
Author(s):  
Simin Farrokhzad ◽  
Mirko Diksic ◽  
Lucas Y. Yamamoto ◽  
William Feindel
Keyword(s):  
Radiochemical Purity ◽  
Specific Activity ◽  
Radiochemical Yield ◽  
Nucleophilic Attack ◽  
Aziridine Ring ◽  
Geometrical Isomers ◽  
Isomeric Mixture

18F-labelled 1,3-bis-(2-fluoroethyl) nitrosourea (18F-BFNU) (9) and 1-(2-chloroethyl)-3-(2-fluoroethyl) nitrosourea (18F-CFNU) (isomeric mixture, 11,12) were synthesized by nucleophilic attack of 18F-labelled tetra-n-butylammonium fluoride on the aziridine ring of 1,3-substituted ureas. Diethyleneurea (DEU) (5), 1-(2-fluoroethyl)-3-ethyleneurea (FEU) (7), and 1-(2-chloroethyl)-3-ethyleneurea (CEU) (14) were used as starting materials in the synthesis. Nitrosation of 18F-labelled 1,3-bis-(2-fluoroethyl) urea (18F-BFU) (6) produced 18F-BFNU with a radiochemical yield of 5–10%. Nitrosation of 18F-labelled 1-(2-chloroethyl)-3-(2-fluoroethyl) urea (18F-CFU) (15) gave 18F-CFNU as a mixture of two isomers. Geometrical isomers of CFNU were separated by hplc, and the radiochemical yield of the two isomers ranged from 8% to 15%, with a radiochemical purity exceeding 96%. Syntheses, which took about 60 min, yielded products with specific activity of 680 mCi/mmol when n-Bu4N+F− was used, or 300 mCi/mmol when HF was used to complete the opening of the aziridine ring.

scholarly journals A New Approach To Produce [18F]MC225 Via One-Step Synthesis, A PET Radiotracer For Measuring P-gp Function.

2021 ◽  
Author(s):  
Lara Garcia Varela ◽  
Khaled Attia ◽  
John Carlo Sembrano ◽  
Olivier Jacquet ◽  
Inês farinha antunes ◽  
...  
Keyword(s):  
Radiochemical Purity ◽  
Synthetic Approach ◽  
Glycoprotein P ◽  
Simple Method ◽  
Synthesis Time ◽  
Molar Activity ◽  
Synthetic Procedure ◽  
One Step ◽  
Formation Method ◽  
The Stability

Abstract Background: [18F]MC225 is a radiotracer for imaging P-glycoprotein (P-gp) function at the blood-brain barrier. The P-gp function can be altered due to different factors, for instance, decreased P-gp function has been described in patients with Alzheimer's or Parkinson's Disease. The current applied radiosynthesis of [18F]MC225 involves 2 steps, including the distillation of [18F]fluoroethylbromide intermediate. To develop a more robust synthetic procedure, it is of interest to produce the radiotracer via 1-step synthesis. The present study describes a new synthetic approach to produce [18F]MC225 via direct 18F-fluorination. Moreover, we also provide the appropriate conditions for the automation of the synthesis. A mesylate precursor was developed via a multi-step synthetic route and used for the radiolabeling. The nucleophilic substitution of the mesylate group by [18F]Fluoride was automated in two different synthesis modules: IBA Synthera and Eckert and Ziegler (E&Z).Results: The mesylate precursor was synthesized in 7 steps starting with 5-hydroxy-1-tetralone (commercially available) in practical yields. The stability of the precursor was improved via mesylate salt formation method. The radiolabeling was done by adding the mesylate precursor dissolved in DMF to the dried [18F]KF/Kryptofix222 complex and heating at 140°C for 30 min. Quality control by UPLC confirmed the production of [18F]MC225 with a molar activity (Am) higher than 20000 GBq/mmol. The synthesis time in Synthera was 106 min and the product was obtained with a radiochemical purity higher than 95% and RCY of 6.5%, while the production in E&Z lasted 120 min and the product had a lower radiochemical purity (91%) and RCY (3.8%).Conclusions: [18F]MC225 was successfully produced via a 1-step reaction. The procedure is suitable for automation using commercially available synthesis modules. The automation of the radiosynthesis in the Synthera module allows the production of the [18F]MC225 by a reliable and simple method.

scholarly journals Synthesis of a novel 89Zr labeled HER2 affibody and its application study in tumor PET imaging

2020 ◽  
Author(s):  
Yuping Xu ◽  
Lizhen Wang ◽  
Donghui Pan ◽  
Junjie Yan ◽  
Xinyu Wang ◽  
...  
Keyword(s):  
Pet Imaging ◽  
Radiochemical Purity ◽  
Ex Vivo ◽  
Radiochemical Yield ◽  
Immunohistochemical Analysis ◽  
In Vivo Studies ◽  
Potential Candidate ◽  
Synthesis Time ◽  
Normal Tissues

Abstract Background: Human epidermal growth factor receptor-2 (HER2) is an essential biomarker for tumor treatment. Affibody is an ideal vector for preparing HER2 specific probes because of high affinity and rapid clearance from normal tissues etc. Zirconium-89 is a PET imaging isotope with a long half-life and suitable for monitoring biological processes for more extended periods. In this study, a novel 89Zr-labeled HER2 affibody, [89Zr]Zr-DFO-MAL-Cys-MZHER2, was synthesized, and its imaging characters were also assessed. Results: The precursor, DFO-MAL-Cys-MZHER2, was obtained with a yield of nearly 50%. The radiochemical yield of [89Zr]Zr -DFO-MAL-Cys-MZHER2 was 90.2±1.9% , and the radiochemical purity was higher than 95%. The total synthesis time was only 30 minutes. The probe was stable in PBS and serum. The tracer accumulated in HER2 overexpressing human ovarian cancer SKOV-3 cells. In vivo studies in mice bearing tumors showed that the probe highly retained in SKOV-3 xenografts even for 48 hours. The tumors were visualized with good contrast to normal tissues. ROI analysis revealed that the average uptake values in the tumor were greater than 5%IA/g during 48 hours postinjection. On the contrary, the counterparts of MCF-7 tumors kept low levels（~1%IA/g）. The outcome was consistent with the immunohistochemical analysis and ex vivo autoradiography. The probe quickly cleared from the normal organs except kidneys and mainly excreted through the urinary system. Conclusion: The novel HER2 affibody for PET imaging was easily prepared with satisfactory labeling yield and radiochemical purity. [89Zr]Zr-DFO-MAL-Cys-MZHER2 is a potential candidate for detecting HER2 expression. It may play specific roles in clinical cancer theranostics.

scholarly journals A new approach to produce [18F]MC225 via one-step synthesis, a PET radiotracer for measuring P-gp function

2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Lara Garcia-Varela ◽  
Khaled Attia ◽  
John Carlo Sembrano ◽  
Olivier Jacquet ◽  
Inês F. Antunes ◽  
...  
Keyword(s):  
Radiochemical Purity ◽  
Synthetic Approach ◽  
Glycoprotein P ◽  
Simple Method ◽  
Synthesis Time ◽  
Molar Activity ◽  
Synthetic Procedure ◽  
One Step ◽  
Formation Method ◽  
The Stability

Abstract Background [18F]MC225 is a radiotracer for imaging P-glycoprotein (P-gp) function at the blood-brain barrier. The P-gp function can be altered due to different factors, for instance, decreased P-gp function has been described in patients with Alzheimer’s or Parkinson’s Disease. The current applied radiosynthesis of [18F]MC225 involves 2 steps, including the distillation of the [18F] fluoroethylbromide intermediate. To develop a more robust synthetic procedure, it is of interest to produce the radiotracer via a 1-step synthesis. The present study describes a new synthetic approach to produce [18F]MC225 via direct 18F-fluorination. Moreover, we also provide the appropriate conditions for the automation of the synthesis. A mesylate precursor was synthesized via a multi-step synthetic route and used for the radiolabeling. The nucleophilic substitution of the mesylate group by [18F] Fluoride was automated in two different synthesis modules: IBA Synthera and Eckert and Ziegler PharmTracer (E&Z). Results The mesylate precursor was synthesized in 7 steps starting with 5-hydroxy-1-tetralone (commercially available) in practical yields. The stability of the precursor was improved via mesylate salt formation method. The radiolabeling was done by adding the mesylate precursor dissolved in DMF to the dried [18F]KF/K2.2.2 complex and heating at 140 °C for 30 min. Quality control by UPLC confirmed the production of [18F]MC225 with a molar activity (Am) higher than 100 GBq/micromole. The synthesis time in Synthera was 106 min and the product was obtained with a radiochemical purity higher than 95% and RCY of 6.5%, while the production in E&Z lasted 120 min and the product had a lower radiochemical purity (91%) and RCY (3.8%). Conclusions [18F]MC225 was successfully produced via a 1-step reaction. The procedure is suitable for automation using commercially available synthesis modules. The automation of the radiosynthesis in the Synthera module allows the production of the [18F]MC225 by a reliable and simple method.

scholarly journals Synthesis of a novel 89Zr labeled HER2 affibody and its application study in tumor PET imaging

2020 ◽  
Author(s):  
Yuping Xu ◽  
Lizhen Wang ◽  
Donghui Pan ◽  
Junjie Yan ◽  
Xinyu Wang ◽  
...  
Keyword(s):  
Pet Imaging ◽  
Radiochemical Purity ◽  
Ex Vivo ◽  
Radiochemical Yield ◽  
Immunohistochemical Analysis ◽  
In Vivo Studies ◽  
Potential Candidate ◽  
Synthesis Time ◽  
Normal Tissues

Abstract Background: Human epidermal growth factor receptor-2 (HER2) is an essential biomarker for tumor treatment. Affibody is an ideal vector for preparing HER2 specific probes because of high affinity and rapid clearance from normal tissues etc. Zirconium-89 is a PET imaging isotope with a long half-life and suitable for monitoring biological processes for more extended periods. In this study, a novel 89 Zr-labeled HER2 affibody, [ 89 Zr]Zr-DFO-MAL-Cys-MZHER2, was synthesized, and its imaging characters were also assessed. Results: The precursor, DFO-MAL-Cys-MZHER2, was obtained with a yield of nearly 50%. The radiochemical yield of [ 89 Zr]Zr -DFO-MAL-Cys-MZHER2 was 90.2±1.9% , and the radiochemical purity was higher than 95%. The total synthesis time was only 30 minutes. The probe was stable in PBS and serum. The tracer accumulated in HER2 overexpressing human ovarian cancer SKOV-3 cells. In vivo studies in mice bearing tumors showed that the probe highly retained in SKOV-3 xenografts even for 48 hours. The tumors were visualized with good contrast to normal tissues. ROI analysis revealed that the average uptake values in the tumor were greater than 5%IA/g during 48 hours postinjection. On the contrary, the counterparts of MCF-7 tumors kept low levels（~1%IA/g）. The outcome was consistent with the immunohistochemical analysis and ex vivo autoradiography. The probe quickly cleared from the normal organs except kidneys and mainly excreted through the urinary system. Conclusion: The novel HER2 affibody for PET imaging was easily prepared with satisfactory labeling yield and radiochemical purity. [ 89 Zr]Zr-DFO-MAL-Cys-MZHER2 is a potential candidate for detecting HER2 expression. It may play specific roles in clinical cancer theranostics.

scholarly journals Robust and Facile Automated Radiosynthesis of [18F]FSPG on the GE FASTlab

2020 ◽  
Author(s):  
Richard Edwards ◽  
Hannah Greenwood ◽  
Timothy Witney
Keyword(s):  
Large Scale ◽  
Radiochemical Purity ◽  
Radiochemical Yield ◽  
Reaction Conditions ◽  
Positron Emission ◽  
Optimized Protocol ◽  
Cancer Types ◽  
Automated Procedures ◽  
Phosphate Buffered Saline ◽  
High Radioactivity

<p><i>Purpose</i>: (S)-4-(3-<sup>18</sup>F-Fluoropropyl)-ʟ-Glutamic Acid ([<sup>18</sup>F]FSPG) is a radiolabeled non-natural amino acid that is used for positron emission tomography (PET) imaging of the glutamate/cystine antiporter, system x<sub>C</sub><sup>-</sup>, whose expression is upregulated in many cancer types. To increase the clinical adoption of this radiotracer, reliable and facile automated procedures for [<sup>18</sup>F]FSPG production are required. Here, we report a cassette-based method to produce [<sup>18</sup>F]FSPG at high radioactivity concentrations from low amounts of starting activity.</p><p><i>Procedures</i>: An automated synthesis and purification of [<sup>18</sup>F]FSPG was developed for the GE FASTlab. Optimization of the reaction conditions and automated manipulations were performed by measuring the isolated radiochemical yield of [<sup>18</sup>F]FSPG and by assessing radiochemical purity using radioHPLC. Purification of [<sup>18</sup>F]FSPG was conducted by trapping and washing of the radiotracer on MCX SepPak catridges, followed by a reverse elution of [<sup>18</sup>F]FSPG in phosphate-buffered saline. Subsequently, the [<sup>18</sup>F]FSPG obtained from the optimized process was used to image an animal model of non-small cell lung cancer.</p><p><i>Results</i>: The optimized protocol produced [<sup>18</sup>F]FSPG in 38.4 ± 2.6% RCY and 96% radiochemical purity. Small alterations, including the implementation of a reverse elution and an altered hypercarb cartridge, lead to significant improvements in radiotracer concentration from <10 MBq/mL to >100 MBq/mL. The improved radiotracer concentration allowed for the imaging of up to 20 mice, starting with just 1.5 GBq of [<sup>18</sup>F]fluoride.</p><p><i>Conclusions: </i>We have developed a robust and facile method for [<sup>18</sup>F]FSPG radiosynthesis in high radiotracer concentration, RCP and RCY. This cassette-based method enabled the production of [<sup>18</sup>F]FSPG at radioactive concentrations sufficient to facilitate large-scale preclinical experiments with a single prep of starting activity. The use of cassettes for an ‘out the box’ synthesis on a synthesis module routinely used for clinical production make the method amenable to rapid and widespread clinical translation.</p>

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