Biomedical Cyclotron
The UCLA Ahmanson Biomedical Cyclotron Facility (BMC) is part of the Department of Molecular and Medical Pharmacology and the Ahmanson Translational Imaging Division.
At UCLA, investigators have translated several new radiopharmaceuticals into the clinic for both imaging and therapy applications. The BMC Facility supports both basic research investigations and patient imaging. Moreover, it supplies a variety of radiopharmaceuticals that can be imaged by methods such as positron emission tomography (PET) and single-photon emission computed tomography (SPECT).
The facility intersects many clinical and research areas including radiochemistry, pharmacology, cancer biology, medicine, chemistry, physics, and engineering.
Our Services
The Cyclotron Facility and Radiochemistry Laboratories:
Our cyclotron facility operates two Siemens RDS 112 cyclotrons that produce Curie levels of positron emitting radioisotopes.
The radiochemistry laboratories are fully equipped with hot cells, Ga-68 generators, radio-HPLCs, dose calibrators, GC/MS instruments, automated radiochemistry systems, synthesis modules for the routine and research production of F-18/C-11/Ga-68 labeled probes. Analytical HPLC systems with a variety of detectors, radio-TLC scanner and GC systems are used for PET probe quality control. The two facilities also have organic chemistry laboratories where multi-step syntheses of tracer precursors and non-radioactive standards can be performed.
The BMC program is focused on the development of radiopharmaceuticals for targeted diagnosis and treatment of cancer. Small molecule radiochemistry, radiolabeling of peptides and monoclonal antibody for radioimmunoimaging, and radioimmunotherapy purposes. Other services offered within the program include design and development of fluorine-18 and carbon-11 agents.
The BMC Facility has successfully synthesized and translated several existing radiopharmaceuticals. Moreover, it is highly committed to developing novel radiopharmaceuticals and translating these agents into the clinic.
Here is a current list of agents we provide.
Regulatory Training
The BMC Facility offers a training/consulting program for other institutions to learn about the following:
- How to prepare chemistry, manufacturing, and control (CMC) documentation for investigational new drug (IND) and new drug applications (NDA) for new radiopharmaceuticals.
- Manufacturing radiopharmaceuticals in compliance with cGMP regulatory requirements.
- Utilizing aseptic techniques while working under GMP conditions
- Developing, validating new analytical methods for quality control.
- Release testing for radiopharmaceuticals manufactured for human use.
- Developing, revising, and managing comprehensive Quality assurance for radiopharmaceuticals release and control.
- Writing and implementing standard operating procedures (SOPs).
Regulatory Compliance
The facility is registered with the FDA as an approved PET radiopharmaceutical manufacture.
Our clinical research radiopharmaceuticals are manufactured in compliance with the FDA’s federal regulation 21CFR212, Current Good Manufacturing Practice for Positron Emission Tomography Drugs (2019); FDA cGMP guidance for PET drugs; and United States Pharmacopeia Chapter 823, Radiopharmaceuticals for Positron Emission Tomography — Compounding.
The facility manufactures radiopharmaceuticals such as 18F-fluorodeoxyglucose, and 13N-ammonia (FDA-approved aNDA compounds).
This program can be tailored toward specific needs. For more information and costs, please contact:
Dr. Giuseppe Carlucci, Biomedical Cyclotron Facility Director
Phone: (310) 794-7638
Email: gcarlucci@mednet.ucla.edu