公开(公告)号：US10109385B2

公开(公告)日：2018-10-23

申请号：US14618732

申请日：2015-02-10

申请人： ABT Molecular Imaging, Inc.

发明人： Aaron McFarland ,  Atilio Anzellotti ,  Daniel Hillesheim ,  Clive Brown-Proctor ,  Mark Haig Khachaturian ,  Andrew Land

IPC分类号： A61K51/00 ,  A61M36/14 ,  G21K5/02 ,  B01J19/00 ,  A61K51/04 ,  A61K51/02

摘要： Microfluidic radiopharmaceutical production system and process for synthesizing per run approximately, but not less than, ten (10) unit doses of radiopharmaceutical biomarker for use in positron emission tomography (PET). A radioisotope from an accelerator or other radioisotope generator is introduced into a reaction vessel, along with organic and aqueous reagents, and the mixture heated to synthesize a solution of a pre-selected radiopharmaceutical. The solution is purified by passing through a combination of solid phase extraction purification components, trap and release components, and a filter. The synthesis process reduces waste and allows for production of biomarker radiopharmaceuticals on site and close to the location where the unit dose will be administered to the patient. On-site, as-needed production of radiopharmaceuticals in small doses reduces the time between synthesis of the radiopharmaceutical and administration of that radiopharmaceutical, minimizing loss of active isotopes through decay and allowing production of lesser amounts of radioisotopes overall.

公开(公告)号：US09686851B2

公开(公告)日：2017-06-20

申请号：US14604192

申请日：2015-01-23

申请人： ABT Molecular Imaging, Inc.

发明人： Ronald Nutt ,  David Patton, Sr. ,  Darrell Swicegood ,  John McCracken ,  Mark Haig Khachaturian

IPC分类号： H05H6/00 ,  G21K5/08 ,  G21G1/10

CPC分类号： H05H6/00 ,  G21G1/10 ,  G21K5/08

摘要： A target assembly to produce radioisotopes for the synthesis of radiopharmaceuticals. The target assembly includes a target vessel with a target chamber adapted to receive a target material. A thin cover sheet of particle-permeable material covers the target chamber. In a bombardment process, a high-energy particle beam generated by a cyclotron or particle accelerator strikes the thin cover sheet, whereby at least some of the particles from the particle beam penetrate to the target chamber so as to interact with the target material, altering the nuclear makeup of some of the atoms in the target material to produce radioisotopes.

公开(公告)号：US08937287B2

公开(公告)日：2015-01-20

申请号：US13451295

申请日：2012-04-19

申请人： Anthony M. Giamis

发明人： Anthony M. Giamis

IPC分类号： G01J1/42

CPC分类号： G01N30/62 ,  G01N2030/77

摘要： A self-referencing radiation detector to test the radiochemical purity of a sample radiopharmaceutical solution. In some embodiments, the self-referencing radiation detector measures the radioactivity of a sample radiopharmaceutical solution before the sample radiopharmaceutical solution is passed through a high performance liquid chromatography column. The radiation detector then measures the radioactivity of each separated molecularly distinct species from the high performance liquid chromatography column. The radiochemical purity of the sample radiopharmaceutical solution is calculated by comparing the measured radioactivity of separated molecularly distinct species from said high performance liquid chromatography column to the measured radioactivity of the sample radiopharmaceutical solution before the sample radiopharmaceutical solution is passed through the high performance liquid chromatography column.

摘要翻译： 一种自参照辐射检测器，用于测试样品放射性药物溶液的放射化学纯度。 在一些实施例中，自参照辐射检测器在样品放射性药物溶液通过高效液相色谱柱之前测量样品放射性药物溶液的放射性。 然后，辐射检测器测量每个分离的分子不同物种与高效液相色谱柱的放射性。 样品放射性药物溶液的放射化学纯度通过将样品放射性药物溶液通过高效液相色谱柱而将样品放射性药物溶液的样品放射性物质与所述高效液相色谱柱分离的分子不同物质的放射性进行比较来计算， 。

公开(公告)号：US20130083881A1

公开(公告)日：2013-04-04

申请号：US13248906

申请日：2011-09-29

申请人： Ron Nutt ,  David Patton, SR. ,  Darrell Swicegood ,  John McCracken

发明人： Ron Nutt ,  David Patton, SR. ,  Darrell Swicegood ,  John McCracken

IPC分类号： G21G1/00

CPC分类号： G21G1/10

摘要： A target assembly to produce radioisotopes for the synthesis of radiopharmaceuticals. The target assembly includes a target vessel with a target chamber adapted to receive a target material. A thin cover sheet of particle-permeable material covers the target chamber. In a bombardment process, a high-energy particle beam generated by a cyclotron or particle accelerator strikes the thin cover sheet, whereby at least some of the particles from the particle beam penetrate to the target chamber so as to interact with the target material, altering the nuclear makeup of some of the atoms in the target material to produce radioisotopes.

公开(公告)号：US20130277566A1

公开(公告)日：2013-10-24

申请号：US13451295

申请日：2012-04-19

申请人： Anthony M. Giamis

发明人： Anthony M. Giamis

IPC分类号： G01N21/84 ,  G01T1/00

CPC分类号： G01N30/62 ,  G01N2030/77

摘要： A self-referencing radiation detector to test the radiochemical purity of a sample radiopharmaceutical solution. In some embodiments, the self-referencing radiation detector measures the radioactivity of a sample radiopharmaceutical solution before the sample radiopharmaceutical solution is passed through a high performance liquid chromatography column. The radiation detector then measures the radioactivity of each separated molecularly distinct species from the high performance liquid chromatography column. The radiochemical purity of the sample radiopharmaceutical solution is calculated by comparing the measured radioactivity of separated molecularly distinct species from said high performance liquid chromatography column to the measured radioactivity of the sample radiopharmaceutical solution before the sample radiopharmaceutical solution is passed through the high performance liquid chromatography column.

摘要翻译： 一种自参照辐射检测器，用于测试样品放射性药物溶液的放射化学纯度。 在一些实施例中，自参照辐射检测器在样品放射性药物溶液通过高效液相色谱柱之前测量样品放射性药物溶液的放射性。 然后，辐射检测器测量每个分离的分子不同物种与高效液相色谱柱的放射性。 样品放射性药物溶液的放射化学纯度通过将样品放射性药物溶液通过高效液相色谱柱而将样品放射性药物溶液的样品放射性物质与所述高效液相色谱柱分离的分子不同物质的放射性进行比较来计算， 。

公开(公告)号：US20130130309A1

公开(公告)日：2013-05-23

申请号：US13446334

申请日：2012-04-13

申请人： Ronald Nutt ,  Antony M. Giamis ,  Aaron McFarland

发明人： Ronald Nutt ,  Antony M. Giamis ,  Aaron McFarland

IPC分类号： G01N30/74 ,  G01N33/60

CPC分类号： G01N30/74 ,  A61K51/0491 ,  B01J19/0093 ,  B01J2219/00788 ,  B01J2219/00873 ,  B01J2219/00891 ,  B01J2219/00905 ,  G01N30/88 ,  G01N33/60 ,  G01N2030/77 ,  G01N2030/8872

摘要： HPLC-based quality control systems to perform quality control testing on a radiopharmaceutical solution shortly after synthesis. An HPLC-based quality control system makes efficient use of sample volume and is compatible with a variety of radioisotopes and radiopharmaceutical compounds. In several embodiments, the automated nature of an HPLC-based quality control system allows for quality control tests to be conducted quickly and with minimal impact on user workflow. When used as part of an integrated PET biomarker radiopharmaceutical production system, the present general inventive concept permits a manufacturer to produce product and conduct quality control tests with lower per dose costs.

摘要翻译： 基于HPLC的质量控制系统，在合成后不久就对放射性药物溶液进行质量控制测试。 基于HPLC的质量控制系统有效利用样品体积，并与各种放射性同位素和放射性药物化合物相容。 在几个实施例中，基于HPLC的质量控制系统的自动化性质允许快速进行质量控制测试并且对用户工作流程的影响最小。 当作为PET生物标志物整合放射性药物生产系统的一部分使用时，本发明总体上允许制造商生产产品并以较低的每剂量成本进行质量控制测试。

公开(公告)号：US08333952B2

公开(公告)日：2012-12-18

申请号：US12565544

申请日：2009-09-23

申请人： Ronald Nutt ,  Anthony M. Giamis ,  Aaron McFarland

发明人： Ronald Nutt ,  Anthony M. Giamis ,  Aaron McFarland

IPC分类号： A61K51/00 ,  A61M36/14

CPC分类号： A61K51/0491 ,  B01J19/004 ,  B01J19/0093 ,  B01J2219/00788 ,  B01J2219/00873 ,  B01J2219/00891 ,  B01J2219/00905

摘要： A microfluidic radiopharmaceutical production system and process for synthesizing per run approximately, but not less than, one (1) unit dose of a radiopharmaceutical biomarker for use in positron emission tomography (PET). The radiopharmaceutical production system includes a reaction vessel that receives a radioisotope from an accelerator or other radioisotope generator. Organic and aqueous reagents are introduced into the reaction vessel, and the mixture is heated to synthesize a solution of a pre-selected radiopharmaceutical. The radiopharmaceutical solution is purified by passing the solution through a solid phase extraction column and a filter. The synthesis process produces per run a quantity of radiopharmaceutical approximately equal to, but not less than, one (1) unit dose of a radiopharmaceutical, reducing waste and allowing for the production of radiopharmaceutical on an as-needed basis. The synthesis process allows for the production of biomarker radiopharmaceuticals on site and close to the location where the unit dose will be administered to the patient. On-site, as-needed production of radiopharmaceuticals in small doses reduces the time between the synthesis of the radiopharmaceutical and the administration of that radiopharmaceutical, thereby minimizing the loss of active isotopes through decay and allowing the production of lesser amounts of radioisotopes overall.

摘要翻译： 一种微流体放射性药物生产系统和用于在正电子发射断层摄影（PET）中使用的放射性药物生物标志物的大约一个但不少于一个单位剂量的放射性药物生物标志物合成的方法。 放射性药物生产系统包括从加速器或其他放射性同位素发生器接收放射性同位素的反应容器。 将有机和含水试剂引入反应容器中，并加热混合物以合成预先选择的放射性药物的溶液。 通过使溶液通过固相萃取柱和过滤器来纯化放射性药物溶液。 合成过程每次产生大约等于但不小于一（1）个单位剂量的放射性药物的放射性药物的量，减少浪费并允许根据需要生产放射性药物。 合成过程允许在现场生产标记放射性药物并且靠近给予患者的单位剂量的位置。 现场按需要的小剂量放射性药物的生产减少放射性药物的合成和放射性药物的给药之间的时间，从而通过衰减使活性同位素的损失最小化，并允许整体产生较少量的放射性同位素。

公开(公告)号：US08080815B2

公开(公告)日：2011-12-20

申请号：US12690900

申请日：2010-01-20

申请人： Ronald Nutt

发明人： Ronald Nutt

IPC分类号： G21G1/10

CPC分类号： G21G1/001 ,  G21G1/10 ,  G21H5/02 ,  H05H13/00

摘要： An improved biomarker generator and a method suitable for efficiently producing short lived radiopharmaceuticals in quantities on the order of a unit dose. The improved biomarker generator includes a particle accelerator and a radiopharmaceutical micro-synthesis system. The micro-accelerator of the improved biomarker generator is optimized for producing radioisotopes useful in synthesizing radiopharmaceuticals in quantities on the order of one unit dose allowing for significant reductions in size, power requirements, and weight when compared to conventional radiopharmaceutical cyclotrons. The radiopharmaceutical micro-synthesis system of the improved biomarker generator is a small volume chemical synthesis system comprising a microreactor and/or a microfluidic chip and optimized for synthesizing the radiopharmaceutical in quantities on the order of one unit dose allowing for significant reductions in the quantity of radioisotope required and the processing time when compared to conventional radiopharmaceutical processing systems.

摘要翻译： 改进的生物标志物发生器和适合于以单位剂量的量级有效地生产短寿命放射性药物的方法。 改进的生物标志物发生器包括粒子加速器和放射性药物微合成系统。 改进的生物标志物发生器的微促进剂被优化用于生产放射性同位素，其用于合成放射性药物，其数量在一个单位剂量的数量级上，与常规的放射性药物回旋加速器相比可显着减小尺寸，功率要求和重量。 改进的生物标志物发生器的放射性药物微合成系统是小体积的化学合成系统，其包含微反应器和/或微流体芯片，并且被优化用于以一个单位剂量的量级合成放射性药物，从而显着减少 与常规放射性药物处理系统相比，所需的放射性同位素和处理时间。