Moving beyond the myth - Meeting the growing demand for Ga-68 radiopharmaceuticals - Cardinal Health
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Moving beyond the myth Meeting the growing demand for Ga-68 radiopharmaceuticals The need for gallium 68 (Ga-68) is here — and it’s growing. Currently, there are nearly 400 clinical trials1 investigating the use of Ga-68 labeled radiopharmaceuticals for the diagnosis of prostate cancer as well as certain other cancers. As demand for the radionuclide continues to grow, there is some perception in the marketplace that supply chain issues will limit the availability of Ga-68 radiopharmaceuticals. Where did this perception come from — and more importantly — are these concerns valid today?
Overcoming the past
At first, the Ga-68 supply chain served the limited needs of academic research
alone. But when commercial applications began to emerge, the supply-
demand balance shifted—and Ga-68 was quickly in short supply.
Germanium-68 (Ge-68)/gallium-68 (Ga-68) generator capacity was extremely
limited when the FDA approved the first commercial Ga-68 radiopharmaceutical.
Because there was only one Ge-68/Ga-68 generator Drug Master File (DMF)
included in the approved drug’s NDA, the entire world relied on a single source
for Ge-68/Ga-68.
Four strategies for meeting
Soon after, a second generator manufacturer filed a DMF and was added to the market demand today:
approved drug’s prescribing information, but both manufacturers had just one
production line for generators. Further, the first Ga-68 radiopharmaceutical was 1. T hree Ge-68/Ga-68 generator DMFs
approved as a single-dose vial, so there was only one patient-ready unit dose and one cyclotron-produced Ga-68
available from each generator elution (and only three generator elutions per day). DMF can be added to new NDA filings.
The result was more demand than available supply of Ga-68.
2. Increased supply of mother nuclide
Fast-forward to today, and these capacity restrictions are no longer an issue, Ge-68 for generator production.
as significantly more Ge-68 production capabilities have come online. Just 3. 100 mCi generators coming soon.
as important, the goal is for Ga-68 radiopharmaceuticals to be produced on-
4. Also coming soon: DMF for solid target
demand by a generator in a nuclear pharmacy, instead of needing to rely on the
developments for Ga-68 production.
scheduled production runs of a cyclotron (more on that in a moment).
Here’s a closer look at how the Ga-68 supply chain will continue to meet the
growing demand for the radionuclide.
Meeting demand today
Generator manufacturers, pharmaceutical companies, and distributors are
“The Galli Eo® generator
collaborating to help ensure a steady supply of Ga-68 radiopharmaceuticals.
For example, there are three approved generator manufacturers today, plus gives providers the flexibility
commercially available liquid targets and synthesis modules for the production of
to create and use patient-
Ga-68 on a cyclotron. Solid target solutions are also being developed.
Belgium-based IRE is increasing generator production, as well as planning
specific doses immediately at
for higher activity generators up to 100 mCi. To help ensure a reliable supply of the site of care.”
germanium, IRE is also building its own cyclotron. “We expect that in the future
there will be intense competition to source germanium due to the anticipated
increase in demand for Ge-68/Ga-68 generators,” said Jean Bonnet, Head of Jean Bonnet
Strategy, Sales and Marketing. Head of Strategy,
“We also know there will be a burst of demand for several months should new Sales and Marketing
Ga-68 based diagnostics — such as Ga-68 PSMA PET — become FDA-approved,” IRE
Bonnet added. “Serving this market requires significant technological expertise
that isn’t widely available. We have that expertise at IRE.”
An essential part of the expertise is the generator itself. Manufactured by IRE
and distributed by Cardinal Health in the United States, the Galli Eo® generator is
approved for use in the preparation of Ga-68 radiopharmaceuticals. The eluate is
delivered in 1.1 mL, achieving high Ga-68 radioactive concentration. The elution
time is less than three minutes, and the small, tabletop footprint requires minimal
Moving beyond the myth: Meeting the growing demand for Ga-68 radiopharmaceuticals 2infrastructure. “One or more Galli Eo® generators can be easily set up in a nuclear
pharmacy to prepare and dispense unit doses for just-in-time delivery to the sites
of care,” Bonnet said. FDA-approved Ga-68 diagnostics
are expanding rapidly
100 mCi generators will provide even more flexibility. “You’ll have more capacity
> Ga-68 dotatate
to elute more often,” he added. “It will double the labeling capacity and be ready
> Ga-68 dotatoc
to elute again in one hour instead of four.”
> Ga-68 PSMA-11
“These higher-activity generators will greatly expand the flexibility that a nuclear
pharmacy has in kit preparation,” said Luke Augustine, Vice President of Business
Development for Cardinal Health Nuclear & Precision Health Solutions. “Three to
four elutions per day could increase up to 10, which will broaden availability.”
There are even more strategies underway to expand availability. As mentioned
earlier, the first commercial Ga-68 radiopharmaceutical was available only as “Health systems that have
a single-dose vial. “In the future, multi-dose kits may be available, allowing
pharmacies to prepare several patient doses from a single kit vial. This will further a Ge-68/Ga-68 generator in
alleviate any remaining concerns about product availability,” Augustine added. their hot lab could prepare
“A higher-activity generator is made for multi-dose vials and higher-volume kits, Ga-68 radiopharmaceuticals
all of which make greater Ga-68 production possible,” said Anthony J. Zinno,
Vice President of Commercial Operations for Telix Pharmaceuticals (US) Inc. themselves or collaborate
Currently, Telix is developing kits for Ga-68 radiopharmaceutical preparation. with a commercial nuclear
For now, these kits are for investigational use in qualified Phase 2 and 3 clinical
pharmacy — or both.
trials. Upon FDA approval, Telix will work with Cardinal Health, the largest nuclear
pharmacy network in the nation, for Ga-68 radiopharmaceutical preparation and
distribution to end-users.
A cyclotron-based product
couldn’t provide this level of
The advantages of pharmacy-prepared Ga-68 flexibility.”
radiopharmaceuticals
The first is broadening access. “Cardinal Health has more than 130 nuclear Anthony J. Zinno
pharmacies across the country, and the vast majority are already licensed for Ge- Vice President,
68/Ga-68 generators. The plan is to have them all licensed, so we can make these Commercial Operations
essential radiopharmaceuticals available to healthcare providers and the patients
they serve,” Augustine said. “Our end goal is to expand access nationwide —
Telix Pharmaceuticals
serving customers with our pharmacy-based strategy.”
Other essential benefits include reliability, flexibility and patient access.
Pharmacy-based generators can prepare the radiopharmaceutical on demand, vs.
The largest nuclear pharmacy network
relying on a GMP-driven manufacturing process that has scheduled production
in the nation with 110+ sites currently
runs each day. Any run failure could cause a significant supply chain disruption
licensed for Ga-68:
leading to delays in delivery and patient care.
In contrast, preparing the final Ga-68 radiopharmaceutical in the pharmacy vs.
manufacturing simplifies the overall process. “The pharmacy-prepared approach
gives providers more flexibility in managing their business operations, as well as
expanding patient access,” Augustine said.
“Providers can use Cardinal Health Nuctrac™ and web ordering technologies to
view Ga-68 availability and schedule patients,” he added. “Just as important, the
supply chain is already built for this type of distribution. There’s literally no change
Moving beyond the myth: Meeting the growing demand for Ga-68 radiopharmaceuticals 3in logistics. Because that’s already in place, pharmacies will be able to ramp up
quickly to serve customers.”
An additional layer of flexibility is with the location of the pharmacy
itself. “Health systems that have a Ge-68/Ga-68 generator in their hot lab
could prepare Ga-68 radiopharmaceuticals themselves or collaborate with
a commercial nuclear pharmacy — or both,” Zinno said. “A cyclotron-based
product couldn’t provide this level of flexibility.”
Managing the half-life of Ga-68
Any Ga-68 supply chain strategy must account for the isotope’s relatively
short half-life. Cardinal Health Nuclear & Precision Health Solutions manages
it via proprietary technologies such as Accutrac™, a system that tracks doses
during transit from the pharmacy to the site of care. The technology also
documents chain of custody and flags any potential delays in delivery. These
capabilities enable Cardinal Health to monitor all doses and act, if needed, to
ensure they are delivered as soon as possible. True to its name, Accutrac™ has a
greater than 99% on-time delivery record2.
“It doesn’t matter if it’s a
Customers can see the status and estimated delivery time for doses whenever
they want via Nuctrac™, the Cardinal Health cloud-native nuclear medicine New York-area hospital or
department management system. “This helps providers know exactly when
a hospital in a remote area,
their doses will arrive, so they can manage their schedules accordingly,”
Augustine said. everybody’s going to have
access to this diagnostic
Into the future technology.”
The goal is to make pharmacy-prepared Ga-68 radiopharmaceuticals
available to as many providers and their patients as possible, no matter
Chris Behrenbruch
where they are. “We anticipate every corner of America will be able to CEO
offer Ga-68 PET imaging to their patients,” said Chris Behrenbruch, CEO of Telix Pharmaceuticals
Telix Pharmaceuticals. “It doesn’t matter if it’s a New York-area hospital or a
hospital in a remote area, everybody’s going to have access to this diagnostic
technology.”
“With the addition of multiple Ge-68 supply sources, as well as the continued
expansion of FDA-approved Ga-68 diagnostics, Ga-68 shortages are a thing of
the past,” Augustine said. “Ga-68 kit preparation in the pharmacy will improve
access to these critical diagnostics, with the goal of achieving availability
similar to that of Tc-99m diagnostics.”
With nuclear pharmacies, pharmaceutical companies and generator
manufacturers working together, the future is bright for those who matter
most: the patients we all serve.
AppliedRadiology. “Nuclear Medicine Prepares for Greater Ga 68 Demand.” March 2021.
Cardinal Health data on file.
2
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ESSENTIAL TO CARE and VITALSOURCE are trademarks of Cardinal Health and may be
registered in the US and/or in other countries. All other marks are the property of their
respective owners. Patent cardinalhealth.com/patents. Lit. No. 1NPS21-1450258 (05/2021)
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