Cyclotron Core

The Cyclotron Core was started to address the unmet needs of bringing investigational radiopharmaceuticals within patient reach. Few academic institutions have a cGMP-compliant cyclotron facility committed to manufacturing research radiopharmaceuticals. This unique situation attracts many investigators and industry sponsors aiming to provide clinical translation of promising radiopharmaceuticals, particularly in preclinical to early phase clinical trials. The Cyclotron Core collaborates with both the Nuclear Pharmacy and PET Imaging Core to provide unmatched translation of novel radiotracers into clinical practice. Additionally, the Cyclotron Core supports the Preclinical Imaging Core with radioisotopes and radiotracers.

Radiopharmaceuticals

FDA Approved for Hospital Clinical Use

  1. [18F] Fludeoxyglucose (Oncology) (multipurpose, diverse, all-purpose, universal, broad spectrum)
  2. [13N]- Ammonia (Cardiology) 
  3. [68Ga] DOTATOC (Oncology)*

 

*Pending FDA ANDA approval

FDA Approved for Research/Investigational Use

Due to proprietary reasons, many of our investigational radiopharmaceuticals are not listed and in varying clinical trial phases for cardiology, oncology, urology, and neurology. Here are a few currently produced radiotracers.

Neurology

    • [11C] ER176 
    • [11C] PiB 
    • [11C] PBR28 
    • [11C] Carfentanil 
    • [11C] P2X7 
    • [11C] UCB-J 
    • [11C] AMPA K2 
    • [18F] SMBT-1 
    • [18F] FAV-1451

    Cardiology

    1. [11C] mHED 
    2. [18F] GP-1* 

    Oncology

    1. [11C] NAMPT*

    Urology

    1. [68Ga] PSMA *

    *Pending FDA ANDA approval

    Cyclotron Services

    1. Contract manufacturing for both in-house and industry sponsored research radiopharmaceuticals
    2. Radiopharmaceutical manufacturing process validation
    3. Perform radiodistribution and radiometabolite testing to determine the degree metabolites will interfere with a diagnostic scan.
    4. Provide preclinical evaluation of radiopharmaceutical toxicity studies
    5. Filing regulatory applications for submission to the FDA such as Investigational New Drug (INDs) and Abbreviated New Drug (ANDAs) applications
    6. Internal quality control testing for radiopharmaceuticals such as radiochemical and radionuclidic tests to pyrogen and sterility tests.

    Equipment

    1. General Electric (GE) PETtrace 16.5 MeV negative ion isochronous cyclotron
    2. Nine ventilated hot cells for housing radiosynthesis modules
    3. Six radiosynthesis modules for production of C11, F18, Ga68, and NH3
    4. Fully equipped quality control laboratory with four Agilent HPLC’s, two Scion GC’s, two TLC scanners, and an MCA
    5. Two ISO 5 dispensing hot cells with telemanipulators for radiopharmaceutical patient specific dose dispensing.
    6. ISO 5 clean room for aseptic assembly of sterile components in manufacturing
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