Low cost and open source purification apparatus for GMP [13N]Ammonia production

Kamar, Farah; Kovacs, Michael S.; Hicks, Justin

doi:10.1016/j.apradiso.2022.110214

Cited by 2 publications

(8 citation statements)

References 7 publications

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“…After initially trying to use latex balloons placed in the DC, we found they were not strong enough to withstand the rapid inflation RIGHT: while the gas is trapped in the DC, the VICI valve is actuated to position B and helium (He) carrier empties the small sample of gas onto the gas chromatograph (GC) for analysis. NAM = in-house designation for solenoid device [10].…”

Section: Resultsmentioning

confidence: 99%

“…There are several limitations or shortcomings that deserve to be mentioned. First, an already constructed device using three-way valves was used [10], but an even simpler twoway valve would suffice. Secondly, as mentioned above we did not test for the presence of either CO or CO 2 gas.…”

Section: Discussionmentioning

confidence: 99%

“…The entire target effluent gas was trapped inside an emptied and dried 1 L sterile water bag (Figure 2). A 30 cm Tefzel tube (3.2 mm id) was attached to the bag to connect to a homemade, dual three-way solenoid device (designated as NAM) [10]. The outlet of the GC sampling loop on the VICI valve was connected to the common port of the first solenoid.…”

Section: Oxygen-15 Quality Testingmentioning

confidence: 99%

“…Similar to previous short-lived isotope productions in our facility [10,11], a pre-release testing protocol was validated for up to two patient doses. A sequence of three batches was performed to represent a QC, dose 1, and dose 2 protocol.…”

Section: Gmp Validationmentioning

confidence: 99%

“…Direct delivery of [ 15 O]O 2 for inhalation is not a new experimental technique [9], but this distance presented a unique challenge. We have devised a pre-release testing and delivery protocol adapted from previously successful strategies for the Current Good Manufacturing Practices (cGMP) manufacturing of [ 13 N]ammonia [10] and [ 15 O]water [11]. Although inline or parallel testing have been reported [9,12], the systems are technically complex, expensive, and could not be operated within close proximity of the PET/MR.…”

Section: Introductionmentioning

confidence: 99%

See 4 more Smart Citations

Frugal and Translatable [15O]O2 Production for Human Inhalation with Direct Delivery from the Cyclotron to a Hybrid PET/MR

Corsaut,

Soto,

Biernaski

et al. 2024

Diagnostics

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Oxygen-15 (β+, t1/2 = 122 s) radiolabeled diatomic oxygen, in conjunction with positron emission tomography, is the gold standard to quantitatively measure the metabolic rate of oxygen consumption in the living human brain. We present herein a protocol for safe and effective delivery of [15O]O2 over 200 m to a human subject for inhalation. A frugal quality control testing procedure was devised and validated. This protocol can act as a blueprint for other sites seeking to implement similar imaging programs.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Oxygen-15 Quality Testingmentioning

confidence: 99%

Section: Gmp Validationmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Frugal and Translatable [15O]O2 Production for Human Inhalation with Direct Delivery from the Cyclotron to a Hybrid PET/MR

Corsaut,

Soto,

Biernaski

et al. 2024

Diagnostics

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A Reliable Production System of Large Quantities of [13N]Ammonia for Multiple Human Injections

et al. 2023

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[13N]Ammonia is one of the most commonly used Positron Emission Tomography (PET) radiotracers in humans to assess myocardial perfusion and measure myocardial blood flow. Here, we report a reliable semi-automated process to manufacture large quantities of [13N]ammonia in high purity by proton-irradiation of a 10 mM aqueous ethanol solution using an in-target process under aseptic conditions. Our simplified production system is based on two syringe driver units and an in-line anion-exchange purification for up to three consecutive productions of ~30 GBq (~800 mCi) (radiochemical yield = 69 ± 3% n.d.c) per day. The total manufacturing time, including purification, sterile filtration, reformulation, and quality control (QC) analyses performed before batch release, is approximately 11 min from the End of Bombardment (EOB). The drug product complies with FDA/USP specifications and is supplied in a multidose vial allowing for two doses per patient, two patients per batch (4 doses/batch) on two separate PET scanners simultaneously. After four years of use, this production system has proved to be easy to operate and maintain at low costs. Over the last four years, more than 1000 patients have been imaged using this simplified procedure, demonstrating its reliability for the routine production of large quantities of current Good Manufacturing Practices (cGMP)-compliant [13N]ammonia for human use.

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Low cost and open source purification apparatus for GMP [13N]Ammonia production

Cited by 2 publications

References 7 publications

Frugal and Translatable [15O]O2 Production for Human Inhalation with Direct Delivery from the Cyclotron to a Hybrid PET/MR

Frugal and Translatable [15O]O2 Production for Human Inhalation with Direct Delivery from the Cyclotron to a Hybrid PET/MR

A Reliable Production System of Large Quantities of [13N]Ammonia for Multiple Human Injections

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