Due to the immense infrastructure and logistical burdens associated with current strategies for radiopharmaceutical production, the proliferation of radiopharmaceuticals beyond the diagnostic agent [18F]FDG has been extremely limited. There are few opportunities to develop and utilize novel “boutique” tracers that could exhibit additional, crucial diagnostic capabilities targeted to individual patient needs. To address this limitation, we have developed a family of simple, inexpensive, microfluidic radiosynthesis devices, termed RAPID (Radiopharmaceuticals As Precision Imaging Diagnostics). Distinguishing features of RAPID devices include very low cost of manufacture, extreme simplicity of use, a disposable “single dose-single device” nature, and the capability to produce enough material for at least one patient dose. We have demonstrated two different prototypes of RAPID chips capable of producing [18F]Fallypride and [68Ga]Ga-PSMA-11 (two positron emission tomography (PET) tracers commonly used in the clinic), thereby showing the ability to employ either fluorine-18 chemistry or gallium-68 chemistry. Both tracers produced with the RAPID technology met FDA quality control standards. We envision that a simple, disposable, low-cost yet robust radiosynthesis platform will enable a paradigm shift in the development, production, and dissemination of radiopharmaceuticals for precision molecular imaging and therapy. Such devices will both serve as tools to facilitate future tracer chemistry development and enable clinicians to access a larger variety of theranostics.

错误:搜索内容不能为空,请输入英文关键词
错误:关键词超出字数限制,请精简
高级检索

Democratizing Radiopharmaceutical Production: The RAPID Chip

  • H. Charles Manning,
  • Federica Pisaneschi,
  • Robert Ta,
  • Mai Lin,
  • Leon M. Bellan

摘要

Due to the immense infrastructure and logistical burdens associated with current strategies for radiopharmaceutical production, the proliferation of radiopharmaceuticals beyond the diagnostic agent [18F]FDG has been extremely limited. There are few opportunities to develop and utilize novel “boutique” tracers that could exhibit additional, crucial diagnostic capabilities targeted to individual patient needs. To address this limitation, we have developed a family of simple, inexpensive, microfluidic radiosynthesis devices, termed RAPID (Radiopharmaceuticals As Precision Imaging Diagnostics). Distinguishing features of RAPID devices include very low cost of manufacture, extreme simplicity of use, a disposable “single dose-single device” nature, and the capability to produce enough material for at least one patient dose. We have demonstrated two different prototypes of RAPID chips capable of producing [18F]Fallypride and [68Ga]Ga-PSMA-11 (two positron emission tomography (PET) tracers commonly used in the clinic), thereby showing the ability to employ either fluorine-18 chemistry or gallium-68 chemistry. Both tracers produced with the RAPID technology met FDA quality control standards. We envision that a simple, disposable, low-cost yet robust radiosynthesis platform will enable a paradigm shift in the development, production, and dissemination of radiopharmaceuticals for precision molecular imaging and therapy. Such devices will both serve as tools to facilitate future tracer chemistry development and enable clinicians to access a larger variety of theranostics.