Loma Linda University (LLU) and Siemens’ PETNET Solutions Inc. have launched a new PET production and research center equipped with a research radiochemistry lab, radiopharmacy and commercial production facility. Together they are going to work to break new ground in biomedical and molecular imaging research and to explore the emerging field of personalized medicine.

The center, which has been named the LLU Center for Imaging Research, is located on the LLU Health campus in California. LLU will operate the radiochemistry lab and the radiopharmacy and commerical product will be handled by PETNET.

It also has two cyclotrons — one dedicated for research and the other for commercial production. Since the isotopes have short half lives, the radiopharmacy and radiochemistry labs have to be next to the cyclotrons.

"PETNET purchased one of the cyclotrons in the facility and is leasing radio pharmacy space in the facility to run a commercial production operation to provide clinical PET radiopharmaceuticals to Southern California hospitals and academic institutions," Dr. Barbara Holshouser of LLU told HCB News. "PETNET provides the regulatory support, maintains, and operates both cyclotrons and works closely with LLU scientists to provide the PET radionuclides needed for molecular imaging research at LLU."

The radiochemistry lab has a synthesis lab with hot cells that protect the operator while they are handling the isotopes. It also has a quality control unit, a clean room hot cell and automated synthesis platforms that include dedicated C-11 acetate, C-11 multi-product, Flourine-18 and O-15 water modules.

Equipment for purifying the agents that are manufactured in the radiochemistry lab will be installed this month, which is the last thing needed before human subject clinical trials can start. Once that’s complete, the lab can be used for both pre-clinical research and clinical trials.

The first project will be to finish a study that’s underway on neuropathic pain in patients with spinal cord injuries. The Department of Defense is largely involved in the new center, having provided funds for this study as well as grants that paid for the cyclotron and other equipment.

The LLU Center for Imaging Research will also take on studies that investigate Alzheimer’s disease in the near future. The center will continue to apply for research grants and participate in upcoming clinical trials.

It’s one of the few sites on the west coast that’s able to both produce PET radiopharmaceuticals and offer imaging so research can be conducted in all disciplines. The clinical doses are produced daily based on customer demand and they are shipped early in the morning throughout Southern California.

The center was completed in February 2015, and a rigorous review was carried out by the FDA and state to ensure it met all of the requirements. On September 17, 2015, PETNET shipped the first clinical dose from the center.

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