公开(公告)号：US20150238918A1

公开(公告)日：2015-08-27

申请号：US14618795

申请日：2015-02-10

Applicant: ABT Molecular Imaging, Inc.

Inventor： Mark Khachaturian ,  Doug Ferguson ,  Aaron McFarland ,  Atilio Anzellotti ,  Clive Brown-Proctor

IPC: B01J19/00 ,  B01J19/08

CPC classification number: A61K51/0491 ,  B01J19/0093 ,  B01J2219/00788 ,  B01J2219/00873 ,  B01J2219/00891 ,  B01J2219/00905 ,  G01N2030/77 ,  G01N2030/8872

Abstract: An automated radiopharmaceutical production and quality control system includes a particle accelerator, a radiopharmaceutical micro-synthesis subsystem, and quality control subsystem. The micro-accelerator of the improved biomarker generator is optimized for producing radioisotopes useful in synthesizing radiopharmaceuticals in quantities on the order of multiple unit doses, allowing for significant reductions in size, power requirements, and weight when compared to conventional radiopharmaceutical cyclotrons. The radiopharmaceutical micro-synthesis subsystem encompasses a small volume chemical synthesis system comprising a microreactor and/or a microfluidic chip and optimized for synthesizing the radiopharmaceutical in small quantities, allowing for significant reductions in processing time and in the quantity of radioisotope required. The automated quality control subsystem is used to test the composition and characteristics of the radiopharmaceutical to ensure that it is safe to inject.

Abstract translation: 自动放射性药物生产和质量控制系统包括粒子加速器，放射性药物微合成子系统和质量控制子系统。 改进的生物标志物发生器的微加速器被优化用于生产用于合成放射性药物的放射性同位素，其数量在多个单位剂量的数量级上，与常规放射性药物回旋加速器相比，允许显着减小尺寸，功率要求和重量。 放射性药物微合成子系统包括小体积的化学合成系统，其包括微反应器和/或微流体芯片，并被优化用于少量合成放射性药物，允许显着减少处理时间和所需放射性同位素的量。 自动质量控制子系统用于测试放射性药物的组成和特性，以确保注射安全。

公开(公告)号：US20150157743A1

公开(公告)日：2015-06-11

申请号：US14618732

申请日：2015-02-10

Applicant: ABT Molecular Imaging, Inc.

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

IPC: A61K51/04 ,  G21K5/02 ,  B01J19/00

CPC classification number: G21K5/02 ,  A61K51/025 ,  A61K51/0402 ,  A61K51/0406 ,  A61K51/0446 ,  A61K51/0453 ,  A61K51/0455 ,  A61K51/0491 ,  B01J19/0093 ,  B01J2219/00788 ,  B01J2219/00873 ,  B01J2219/00891 ,  B01J2219/00905 ,  B01J2219/00909

Abstract: 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.

Abstract translation: 微流体放射性药物生产系统和用于合成正电子发射断层扫描（PET）的大约但不小于十（10）个单位剂量的放射性药物生物标志物的方法。 来自加速器或其他放射性同位素发生器的放射性同位素与有机和含水试剂一起引入反应容器中，并将混合物加热以合成预先选定的放射性药物的溶液。 通过通过固相萃取纯化组分，捕集和释放组分和过滤器的组合来纯化溶液。 合成方法减少了废物，并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。 在现场，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该放射性药物的给药之间的时间，通过衰减最小化活性同位素的损失，并允许总体产生较少量的放射性同位素。

公开(公告)号：US10109385B2

公开(公告)日：2018-10-23

申请号：US14618732

申请日：2015-02-10

Applicant: ABT Molecular Imaging, Inc.

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

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

Abstract: 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：US20150160171A1

公开(公告)日：2015-06-11

申请号：US14618772

申请日：2015-02-10

Applicant: ABT Molecular Imaging, Inc.

Inventor： Atilio Anzellotti ,  Aaron McFarland ,  Clive Brown-Proctor ,  Daniel Hillesheim ,  Mark Khachaturian

IPC: G01N30/74

CPC classification number: G01N30/74 ,  A61K51/0491 ,  B01D15/08 ,  B01J19/0093 ,  B01J2219/00788 ,  B01J2219/00873 ,  B01J2219/00891 ,  B01J2219/00905 ,  G01N30/88 ,  G01N2030/027 ,  G01N2030/77 ,  G01N2030/8872

Abstract: An automated HPLC-based quality control system to perform quality control testing on a radiopharmaceutical solution shortly after synthesis. An automated 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 automated 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 and shorter testing times.

Abstract translation: 一种基于HPLC的自动化质量控制系统，可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的自动化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的自动化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，本发明的总体构思允许制造商生产产品并以较低的每剂量成本和较短的测试时间进行质量控制测试。