Challenge

bioscan

Bioscan, a client of MPR Associates, was founded in 1980 as a supplier of innovative products for radioisotope detection and analysis in life science, pharmaceutical and nuclear medicine research applications.  The company's move into Positron Emission Tomography (PET) chemistry began in the late 1990s as an outgrowth of its involvement in nuclear medicine.  During the past three years, MPR's Technology Group has been working with Bioscan on the introduction of the PET Chem-Series III product line, a complete product suite for use in PET imaging studies.  During that time, MPR has conducted several separate engineering assignments for Bioscan.  Each of the products in the Chem-Series III suite has been designed so that it could be used as a stand-alone unit or as part of the integrated product suite. 

For this project, MPR was charged with designing an efficient and easy-to-use system for the labeling of PET tracers, including C-11 methylations and F-18 fluoroalkylations.  The challenge was to transfer a revolutionary radiopharmaceutical synthesis process from a university lab into a marketable product within a short time period.  Previous C-11 radiopharmaceutical production systems had typically been homemade units that were difficult to use, expensive to maintain and clean, inefficient in their use of reagents and inconsistent in product yield. 

Bioscan also sought flexibility in the product's design.  The AutoLoop system needed to be designed so that it could be configured with the MeI-Plus module as a complete C-11 synthesis system or as a stand-alone unit solely for radioactive tracer production automation.

Approach

bioscan

On the AutoLoop, MPR's project team quickly set out to identify and solve the limiting technical issues with simultaneous hardware, software and fluidics design.  The first step was proving the concept's underlying technology.  In doing so they identified several specific issues, including production in a hot cell requiring hands-off processing and self-cleaning, processing of minute quantities of chemicals, and fast turn-around for each batch.  The next step was to develop a prototype to validate the system's commercial design, which included automating the synthesis of injectable radio-labeled compounds used for Positron Emission Tomography (PET), an imaging technique that produces three-dimensional views of the heart, brain and other body organs. 

Solution

MPR engineers took the AutoLoop project from concept to final design, executing the project on a turnkey basis.   The result was the introduction of a total platform design that encompassed:

  1. integrated hardware and software,
  2. automated process control, and
  3. robust industrial components in a sleek package.

A prototype of the AutoLoop system, complete with companion system software, was rapidly created in less than three months and made available for preview at the International Society of Nuclear Medicine Industry trade show in 2001.  AutoLoop can be configured with the MeI-Plus module as a complete C-11 synthesis system or it can operate as a stand-alone system.  To economize on space, a number of components, such as the control interface, solvent delivery and waste modules can be shared.  The system has built-in radiation detectors to enable real time monitoring of the radioactivity in the AutoLoop and waste.  The user can easily follow the labeling process using the real-time display features on the PET Chem/Series III software that MPR created.

 

Benefit

Working in collaboration with Bioscan, MPR's project team took a university lab concept and developed a successful commercial product in less than 12 months.  The AutoLoop system, which sets a new standard for ease-of-use and efficiency when labeling with C-11 and F-18, has proven to be reliable for generating consistently high product yields.  The system's automatic operation and cleaning design enables a turnaround of 30 minutes or less.  The modular design also saves valuable hot cell space.

The AutoLoop system is being used in labs worldwide with great results.  In addition, MPR Associates and Bioscan currently have an international patent pending for the design and application of this first-of-its-kind carbon-11 based radiopharmaceutical synthesis system.