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Production of radiometal-based radiopharmaceuticals at a clinical scale via droplet-scale radiochemistry

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41EB034168-01A1
Agency Tracking Number: R41EB034168
Amount: $275,773.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIBIB
Solicitation Number: PA22-178
Solicitation Year: 2022
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-09-01
Award End Date (Contract End Date): 2024-08-31
Small Business Information
Sherman Oaks, CA 91403-4303
United States
DUNS: 118626333
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (440) 773-6852
Business Contact
Phone: (626) 807-2233
Research Institution
LOS ANGELES, CA 90095-2000
United States

 Nonprofit College or University

Despite the enormous value of radiopharmaceuticals for imaging and therapy in clinical nuclear medicine, and
for research and drug development, the production of these compounds remains very expensive because of
the need for complex, capital-intensive equipment and infrastructure (i.e., hot cells, stack monitor,
radiosynthesizer, and a suite of QC testing equipment) at each site. For the most widely used PET
radiopharmaceutical, [18F]FDG, multiple patients can be scheduled on the same day, enabling the batch
production costs to be divided among many individual doses. However, for most other PET tracers, such
cost-sharing opportunities are rare or non-existent, meaning that each production run is effectively dedicated to
a single patient, resulting in a high cost per patient dose. These challenges discourage manufacturers from
investing in the production of valuable but less-used radiopharmaceuticals, which severely limits their
availability. Additionally, the high price of many radiopharmaceuticals discourages their use in research (e.g.
pre-clinical), and hampers the development and validation of novel radiopharmaceuticals. In addition to limited
demand, some radiopharmaceuticals are constrained by supply-side issues (e.g. limited output of Ga-68
generators) that inherently limits the number of patient doses that can be made in a single batch.
Instead of relying on cost reductions through increased demand for radiopharmaceuticals and increase size of
batches produced, which will be impossible for many cases, our strategy is to lower the batch production cost
itself. New microfluidic methods of PET tracer manufacture have emerged in recent years with the potential to
revolutionize tracer production via dramatic reductions in cost and complexity. The droplet-based approach
developed by the van Dam laboratory at UCLA enables the production of numerous 18F-radiopharmaceuticals
with ~100x reagent reduction, 2-3x reduction in synthesis and purification time, and high molar activity, all in a
system the size of a coffee cup. Droplet reactions were scaled to clinically-relevant amounts (one to many
patient doses) by using an upstream radioisotope concentrator.
DropletPharm, Inc. is commercializing a benchtop radiopharmacy platform based on this technology that will
enable a transformation to low-cost production of a broad range of radiopharmaceuticals. Though most of the
prior development of droplet radiochemistry has focused on 18F-radiopharmaceuticals, there is intense interest
in radiometal isotopes for imaging and therapy, with a large number of Ga-68 compounds in pre-clinical
development, clinical trials and a few with FDA-approval for routine use. In this Phase I STTR project, we aim
to expand the applications of DropletPharm’s droplet radiochemistry approach beyond F-18 radiotracers by
building a metal-free droplet reactor and establishing the feasibility of radiometal labeling. We will develop
radioisotope concentration methods for Ga-68, Cu-64, and Zr-89 (Aim 1), develop droplet labeling methods for
example radiotracers (Aim 2), and demonstrate production of [68Ga]Ga-PSMA-11 in a cGMP setting (Aim 3).

* Information listed above is at the time of submission. *

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