ImmunoPET Imaging allows visualization of biological processes in the body via radiolabeled monoclonal antibodies
(mAb’s) with Positron Emission Tomography (PET). ImmunoPET has proven to be a groundbreaking innovation yielding
actionable medical information that is not otherwise obtainable in many disease areas. However, ImmunoPET imaging is
only available at select academic centers limited by complexity of production of short-lived Zr-89-radiolabeled antibodies.,
which prevents access of ImmunoPET to the majority of patient population and to clinical trial utilization.
To address this barrier, Trace-Ability will develop Tracer-ONE – compact and affordable automation of the entire [Zr-
89]mAb production procedure including radio-labeling, QC and immunoassay with results available before the PET scan.
Production staff will need only to install a kit, add the radionuclide, initiate the process and return to collect the product
along with QC report. Such solution will enable any facility with limited staff and budget to start producing ImmunoPET
tracers in a scalable, standardized, safe and GMP-compliant manner.
Key new capabilities needed for Tracer-ONE have been demonstrated in Phase I including radiolabeling,
immunoreactivity assay and most QC tests. Phase II is designed to deliver a fully-functional system suitable for cGMP
production of a variety ImmunoPET tracers for clinical use. To maximize the immediate impacts of the project, we chose
the HIV application of ImmunoPET, currently limited to a single location in the US. To demonstrate the scalability of
Tracer-ONE, we will sequentially enable two HIV ImmunoPET tracers starting with [Zr-89]VRC01.
Specific Aim 1 Develop fully automated [Zr-89]VRC01 radio-synthesis starting with [Zr-89]oxalate and a disposable
kit and yielding [Zr-89]VRC01 that meets all requirements for clinical use. Specific Aim 2 Develop fully automated [Zr-
89]VRC01 quality control including immunoreactivity. The deliverable of this aim is to design a disposable kit and
corresponding protocol to enable all measurements required prior to clinical use of [Zr-89]VRC01. Specific Aim 3 Optimize
Tracer-ONE for fully automated production of [Zr-89]VRC01 for clinical use. The ultimate deliverable of this aim is
acceptance of the system’s performance by UCSF quality and regulatory groups. Specific Aim 4 Demonstrate efficient
expansion of established Tracer-ONE capabilities to another HIV ImmunoPET tracer. The deliverable of this aim is a fully
automated radiosynthesis and QC process on Tracer-ONE qualified for a second HIV tracer at UCSF and meeting the same
acceptance criteria as [Zr-89]VRC01.
The outcome of the project is principal enablement of a capability that does not exist today – routine ImmunoPET
tracer production across a diverse range of products leading to broad availability of ImmunoPET imaging to American
patients in AIDS, cancer, arthritis and other disease areas. In additional to diagnostic value, broad availability of
ImmunoPET will increase the effectiveness of clinical trials and availability of new therapies and the percentage of patients
that respond to therapies.
