SBIR-STTR Award

Commercialization of a Microscale, Point of Use Radiosynthesis Device for the Development and Production of PET Probes
Award last edited on: 9/16/2013

Sponsored Program
SBIR
Awarding Agency
DOE
Total Award Amount
$1,145,467
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Melissa Esterby

Company Information

Sofie Biosciences Inc

6162 Bristol Parkway
Culver City, CA 90230
   (310) 242-6794
   inquiry@sofiebio.com
   www.sofiebio.com
Location: Single
Congr. District: 37
County: Los Angeles

Phase I

Contract Number: ----------
Start Date: ----    Completed: ----
Phase I year
2011
Phase I Amount
$150,000
Positron Emission Tomography (PET) is a molecular imaging modality that utilizes radiolabeled molecules (probes) to target and measure biological processes. Basic scientists can use the same probes to examine microorganisms, cells, and mice as they do in patients to visualize and characterize the biology of disease, monitor its progression, and evaluate therapeutic efficacy. Although over 1,600 PET probes have been developed to help answer a variety of biological questions, only the glucose analog ([18F] FDG) is routinely used. This limitation exists because of the centralized radiopharmacy approach to PET probe production, with its complexity, high infrastructure cost, and necessity of specialized equipment and skilled personnel. A decentralized approach to PET probe development is required to give scientists the freedom to determine what probes they want to use to best solve the problems of their interest. This goal can be achieved by building a benchtop, PC-controlled, microfluidic chip-based commercial device for the on-demand production of PET probes. Phase I of this project will answer basic commercial feasibility questions about the underlying Electro-Wetting-On-Dielectric (EWOD) microfluidic chip technology, while Phase II will produce a commercial prototype of the device, complete with a PC-based control system that contains an inexpensive, disposable, probe-specific cartridge of the microfluidic chip and associated reagents. As an eventual product, a library of chips will be developed based on customer needs for different probes. Shifting to a point-of-research/point-of-care model is a transformational solution that removes the limitations imposed by the centralized model on probe production, cost, and diversity. By empowering scientists and clinicians to control the development and use of PET probes, they are able to focus on processes that they believe are most important for the environmental and biological sciences.

Phase II

Contract Number: ----------
Start Date: ----    Completed: ----
Phase II year
2012
Phase II Amount
$995,467
Positron Emission Tomography (PET) is a molecular imaging modality that utilizes radiolabeled molecules (probes) to target and measure biological processes. Basic scientists can use the same probes to examine microorganisms, cells, and mice as they do in patients to visualize and characterize the biology of disease, monitor its progression, and evaluate therapeutic efficacy. Although over 1,600 PET probes have been developed to help answer a variety of biological questions, and could potentially lead to new diagnostic and therapeutic tools for further study, only the glucose analog 2-[18F]fluoro-2-deoxy-D-glucose ([18F]FDG) is routinely used. This limitation exists because of the centralized radiopharmacy approach to PET probe production, with its complexity, high infrastructure cost, and necessity of specialized equipment and skilled personnel. An alternative, decentralized approach to PET probe development is required to give scientists the freedom to determine what probes they want to use to best solve the problems of their interest. This goal can be achieved by building a benchtop, computer-controlled, microfluidic chip-based commercial device for the on-demand production of PET probes. Phase I of this project answered basic commercial feasibility questions about the underlying Electro- Wetting-On-Dielectric (EWOD) microfluidic chip technology, including: (1) the suitability of EWOD chips based on printed-circuit-board (PCB) technology to reduce costs of radiosynthesis chips; (2) the repeatability of synthesis process parameters and outcomes; (3) coupling of a miniature purification system to the prototype chip; and (4) establishing the versatility of the platform through synthesis of additional PET compounds other than [18F]FDG. Phase II will produce a commercial prototype platform for the point-of-use production of PET probes. This platform will include: (1) a computer-based control system; (2) an inexpensive, disposable, probe- specific cassette of chips and reagents; and (3) a compact, benchtop housing that serves to shield the end user from radiation. As an eventual product, a library of cassettes will be developed based on customer needs for different probes. Shifting to a point-of-research/point-of-care model is a transformational solution that circumvents the limitations imposed by the centralized model on probe production, cost, and diversity. By empowering scientists and clinicians to control the development and use of PET probes, they are able to focus on processes that they believe are most important for the environmental and biological sciences.