Radiopharmaceutical Production Facility
A facility designed for the production of radiopharmaceuticals for preclinical and clinical research
Mission
The University of Wisconsin Radiopharmaceutical Production Facility (RPF) is situated within the Wisconsin Institutes of Medical Research, located at the University of Wisconsin School of Medicine and Public Health. The RPF houses a manufacturing area designed for the cGMP production of radiopharmaceutical agents for translational clinical research and human clinical use. This facility is staffed by experienced radiochemists and nuclear pharmacists, responsible for ensuring that the manufactured radiopharmaceuticals are cGMP compliant.
About the Facility
The University of Wisconsin Radiopharmaceutical Production Facility (RPF) is situated within the Wisconsin Institutes of Medical Research, located at the University of Wisconsin School of Medicine and Public Health. It houses a new manufacturing area designed for the production of cGMP radiopharmaceuticals. This area is equipped with multiple hot cells and synthesis modules and includes multiple quality control instruments to accommodate segregation of clinical (USP <823>) and preclinical production activities. Additionally, a dispensing area designed in compliance with USP <825> has the capability to compound and distribute radiopharmaceuticals.
Services and Interests
- PET radiopharmaceutical production and imaging to support human clinical studies
- Production of literature PET (small molecule and biologics) and radiotherapy agents
- Preclinical and clinical development of novel PET imaging and therapeutic agents
- Production of 18F, 11C, 13N-ammonia, and 68Ga PET radiopharmaceuticals
- On-site availability of 89Zr and 64Cu radioisotopes for research
- Request Radiopharmaceutical Assessment and Development
Nuclear Pharmacy
- Shielded fume hoods for custom compounding
- Laminar Flow hoods
- Designed for USP <797> compliance
- Dispensing area for distribution
Manufacturing
- Multiple Bq and Sv Production Hot Cells
- Custom-Made Hot Cells
- Multiple Synthesis Modules
- Laminar Flow Hood
- 68Ga Generator
Quality Control
- Gas Chromatographs
- HPLC Units
- Multi-Channel Analyzers
- Dose Calibrators
- TLC Scanner
- Biological Safety Cabinets
- Incubators
Molecular Imaging
The molecular imaging research program at the University of Wisconsin (UW) is composed of a multi-disciplinary team including researchers, physicians, radiopharmaceutical production staff, technologists, supporting staff, and graduate students. The primary focus of the program is to develop new molecular imaging agents, translate new molecular imaging agents into the clinic, and discover new applications of…
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Molecular Imaging
The molecular imaging research program at the University of Wisconsin (UW) is composed of a multi-disciplinary team including researchers, physicians, radiopharmaceutical production staff, technologists, supporting staff, and graduate students. The primary focus of the program is to develop new molecular imaging agents, translate new molecular imaging agents into the clinic, and discover new applications of existing molecular imaging agents. UW houses world-class infrastructure fostering research along the entire chain of molecular imaging – from radioisotope production to image analysis. Equipment available to researchers includes a cyclotron, a GMP radiopharmaceutical production facility, clinical and pre-clinical PET/CT scanners, a PET/MR scanner, and computing resources.
UW is actively developing and testing new molecular imaging agents for clinical use in diagnosis and treatment response assessment. Radiopharmaceuticals being tested for clinical applications include: 18F-DCFPyL, a prostate-specific membrane antigen PET agent that has been shown to be highly effective in prostate cancer detection; 18F-FLT, a marker of proliferation that has promising applications in treatment response assessment for various cancers and therapies; and 124I-CLR1404, a phospholipid ether analogue developed at UW by Dr. Jamey Weichert’s contrast agent lab that has demonstrated selective uptake in a variety of tumor models.
Molecular imaging agents being developed and tested in a pre-clinical environment include a wide variety of labeled peptides, proteins, antibodies, and antibody fragments for PET, optical, and photoacoustic imaging, as well as multimodal molecular imaging agents that can provide complementary and/or synergistic information via combinations of these imaging techniques. In addition, UW is expanding the critical roles that molecular imaging can play in image-guided drug delivery to cancer and various other diseases with biocompatible/biodegradable nanomaterials (e.g., silica-based, polymer-based, among others).
For clinically-available molecular imaging agents, UW is discovering new methods and applications in quantitative PET imaging. Research interests include quantitative imaging biomarkers of treatment response, automated analysis of 18F-NaF PET/CT imaging, applications of machine learning into PET/CT image analysis, quantitative harmonization of PET scanners, PET/MR imaging, and PET tumor segmentation algorithms, among others.
UW’s molecular imaging research program is enriched by its many collaborative relationships with other departments and institutions. Notably, collaborations between UW and General Electric Healthcare have led to multiple joint molecular imaging research projects. Additionally, through the Wisconsin Oncology Network for Imaging Excellence (WONIX) initiative, UW collaborates with various institutions throughout Wisconsin, providing access to advanced molecular imaging agents, clinical trials, and centralized image analysis.
Make A Request
Radiopharmaceutical Assessment and Development Request Form (PDF)
Use the form above for all requests to produce PET Drugs in the University of Wisconsin Radiopharmaceutical Production Facility (RPF). Please provide the following information to best enable us to efficiently process your request for manufacturing PET drugs in the RPF. This request should be completed prior to submitting a grant application or protocol submission to the IRB. If you have questions regarding the information being requested, please email RadiologyRPForm@UWHealth.org or phone (608) 265-2435.
Available Radiopharmaceuticals
FDA DMF-Filed
- 18F-FLT ([18F] Fluorothymidine)
- 18F-FES ([18F] Fluoroestradiol)
- 18F-FCH ([18F] Fluoromethylcholine)
- 18F-FFNP ([18F] labeled Progesterone analog)
- 18F-SynVesT-1 ([18F] labeled small molecule SV2A agent)
- 68Ga-FAPI-46 (fibroplast activation protein inhibitor agent)
FDA Approved ANDA
- 13N-Ammonia (Myocardial perfusion agent)
FDA Approved Kits
- 68Ga-DOTATOC (Somatostatin receptor agent)
- 68Ga-PSMA (HBED-CC or PSMA-11; [68Ga] labeled small molecule PSMA agent)
- 68Ga-DOTATATE (Somatostatin receptor agent)
Personnel
Director
Associate Director
Radiopharmacist
Scientific Staff
Contact
For more information about the Radiopharmaceutical Production Facility:
Director
Radiopharmacist
Physical Location
Wisconsin Institutes for Medical Research (WIMR)
B1306 WIMR, 1111 Highland Avenue
Madison, WI 53705-2275
