Ginkgo Bioworks and partners awarded
$29 million contract by ARPA-H to
develop distributed manufacturing of essential medicines using
wheat germ cell-free expression systems
BOSTON, April 10,
2025 /PRNewswire/ -- Ginkgo Bioworks (NYSE:
DNA), which is building the leading platform for cell programming
and biosecurity, today announced a new contract with the
Advanced Research Projects Agency for Health (ARPA-H),
alongside partners Tritica Biosciences, US
Pharmacopeia (USP), On Demand Pharmaceuticals,
and Isolere Bio by Donaldson. This two-year program,
Wheat-based High efficiency Enzyme and API Technology (WHEAT), aims
to establish a new manufacturing process for the distributed
production of biologic and small molecule active pharmaceutical
ingredients (APIs) using wheat germ cell-free expression
systems.
Under the $29 million
contract, Ginkgo will combine its Enzyme Services and
expertise in cell-free systems with the expertise and experience of
its partners in upstream extract preparation, API downstream
processing, quality metrics, and modular, on-demand API
manufacturing methods, with the aim of developing affordable
cell-free biological processes to produce essential medicines. By
utilizing wheat germ - an abundant and renewable resource - and
developing methods to produce medicines exactly where and when they
are needed, the partnership seeks to create a new paradigm for
domestic manufacturing of critical medicines, stabilizing and
reshoring supply chains for essential pharmaceuticals. This
strategy shifts API production from fragile global supply chains to
a robust, decentralized system using Cell-Free Protein Synthesis
(CFPS).
Bringing the Kernel of Innovation from Farm to
Pharma
The project brings together non-profit and corporate partners
based in Massachusetts,
Kansas, Maryland, and Minnesota, combining expertise to develop
scalable, distributed manufacturing solutions to strengthen supply
chain resilience for active pharmaceutical ingredients. Ginkgo
Bioworks will apply its cell programming platform, utilizing
machine learning, computational tools, and predictive approaches to
engineer enzymes and optimize cell-free expression systems.
"We are thrilled for the opportunity to work on this
exciting project with ARPA-H and our teammates to allow Americans
to reap the benefits when we bring together innovations in farm and
pharma," said Jesse Dill, Senior
Director of Business Development at Ginkgo Bioworks. "From
small molecule compounds to biologics, we believe this project can
sow the seeds of medical innovation, growing a new manufacturing
paradigm for essential medicines using affordable cell-free
biological processes, to reshore and stabilize these critical,
life-saving supply chains."
WHEAT aims to demonstrate scalable and decentralized
processes for CFPS-based production of complex APIs, focusing on
targets where biocatalysis can wholly or partially complete
syntheses, and where current supply chains are constrained to
natural products or overseas providers. Additionally, WHEAT's
innovations in protein post-translational modifications (PTMs) aim
to establish a foundation suitable for production of biologics such
as growth factors and insulin, offering a broader range of
applications and establishing a foundation for further expanding
the potential of CFPS to even more complex products.
An Integrated Platform Addressing Cost, Distribution,
and Quality Needs
"At Tritica Biosciences, we are excited to collaborate with
Ginkgo Bioworks and our partners to revolutionize pharmaceutical
manufacturing," said Chris
Miller, Founder and CSO of Tritica Biosciences. "By
harnessing the power of wheat germ cell-free systems, we're
planting the future of medicine, helping to make production more
efficient, flexible, and localized."
"Economic and supply chain security for essential medicines is
critical," said Eugene Choi,
President and COO of On Demand Pharmaceuticals. "This
collaboration brings together innovative technologies and expertise
to transform how we produce and access these vital drugs."
"Advanced manufacturing technologies and biomanufacturing are
critical to bolstering supply chain resilience," said
Ronald T. Piervincenzi, Ph.D., CEO
of USP. "USP is proud to contribute our scientific expertise to
develop standardized solutions, process control strategies, and
quality testing methods that pave the way for broader adoption,
future regulatory approval and commercialization."
"Isolere Bio by Donaldson is
eager to collaborate with these great organizations on this
transformative product," said Michael
Dzuricky, Director of R&D at Isolere Bio by Donaldson. "The goals of this project
align perfectly with our life science vision of building innovative
bioprocessing solutions that can reduce costs and increase speed of
development for essential reagents and medicines."
Sowing the Future of Medicine
This program represents one of the first initiatives within
ARPA-H's Scalable Solutions Office, aimed at transforming the
health of all Americans by improving the speed, scale, and access
to medical treatments and enhancing health security in the US. By
establishing a faster and cheaper way to develop essential
medicines, the collaboration positions Ginkgo Bioworks as a leader
in cell-free small molecule and biologics manufacturing, leveraging
its engineering capabilities and experience at
scale.
About Ginkgo Bioworks
Ginkgo Bioworks is the leading horizontal platform for cell
programming, providing flexible, end-to-end services that solve
challenges for organizations across diverse markets, from food and
agriculture to pharmaceuticals to industrial and specialty
chemicals. Ginkgo Biosecurity is building and deploying the
next-generation infrastructure and technologies that global leaders
need to predict, detect, and respond to a wide variety of
biological threats. For more information, visit
ginkgobioworks.com and
ginkgobiosecurity.com, read our blog, or
follow us on social media channels such as X (@Ginkgo
and @Ginkgo_Biosec), Instagram
(@GinkgoBioworks), Threads
(@GinkgoBioworks), or LinkedIn.
GINKGO BIOWORKS INVESTOR
CONTACT:
investors@ginkgobioworks.com
GINKGO BIOWORKS MEDIA
CONTACT:
press@ginkgobioworks.com
About Tritica Bio
At Tritica Biosciences, we are revolutionizing synthetic biology
through a groundbreaking technology designed for rapid discovery,
prototyping, and manufacturing, with applications from farm to
pharma. Our focus is innovation, and we are committed to
accelerating the bio-manufacturing process and delivering new
products that address global challenges in biotechnology.
Our proprietary strain-free discovery platform, seamlessly
integrated with scaled production, enables us to iterate, optimize,
and launch products at unprecedented speeds. Founded in 2017,
Tritica Biosciences is driven by a team of experts dedicated to
pushing the boundaries of biotechnology.
For more information visit triticabio.com or find us
at LinkedIn.
About US Pharmacopeia
USP is an independent scientific organization that
collaborates with the world's top experts in health and science to
develop quality resources and standards for medicines, dietary
supplements, and food ingredients. Through our resources,
standards, advocacy and education, USP helps increase the
availability of quality medicines, supplements and foods for
billions of people worldwide. For more information,
visit: www.usp.org.
About On Demand Pharmaceuticals
On Demand Pharmaceuticals is a new kind of pharmaceutical
company. We are focused on providing healthcare professionals and
their communities access to the most agile medicine-making
capabilities, including subscription services ("Medications as a
Service") and point of care delivery systems ("Pharmacy on Demand")
that integrate production oversight innovations with our robust
formulary. Our enabling capabilities in drug substance and drug
product are vertically integrated to produce a robust and resilient
supply chain that meets our customers' needs.
About Isolere Bio by Donaldson
Isolere Bio by Donaldson is an
innovator in biopharmaceutical purification technologies,
specializing in streamlined solutions for complex biologics. The
company works diligently to enhance the efficiency, purity and
cost-effectiveness of biopharmaceutical processes by leveraging
cutting-edge materials into next generation solutions. Each product
is designed with scalability and sustainability in mind to enable
customers to rapidly and reliably commercialize life-saving
therapies. For more information, visit
www.isolerebio.com.
Incorporated in 2017, Isolere Bio became part of Donaldson
Company (NYSE: DCI) in early 2023.
For more information, visit
isolerebio.com.
Forward-Looking Statements of Ginkgo Bioworks
This press release contains certain forward-looking statements
within the meaning of the federal securities laws, including
statements regarding the capabilities and potential success of the
partnership and Ginkgo's cell programming platform. These
forward-looking statements generally are identified by the words
"believe," "can," "project," "potential," "expect," "anticipate,"
"estimate," "intend," "strategy," "future," "opportunity," "plan,"
"may," "should," "will," "would," "will be," "will continue," "will
likely result," and similar expressions. Forward-looking statements
are predictions, projections and other statements about future
events that are based on current expectations and assumptions and,
as a result, are subject to risks and uncertainties. Many factors
could cause actual future events to differ materially from the
forward-looking statements in this press release, including but not
limited to: (i) our ability to realize near-term and long-term cost
savings associated with our site consolidation plans, including the
ability to terminate leases or find sub-lease tenants for unused
facilities, (ii) volatility in the price of Ginkgo's securities due
to a variety of factors, including changes in the competitive and
highly regulated industries in which Ginkgo operates and plans to
operate, variations in performance across competitors, and changes
in laws and regulations affecting Ginkgo's business, (iii) the
ability to implement business plans, forecasts, and other
expectations, and to identify and realize additional business
opportunities, including with respect to our solutions and tools
offerings, (iv) the risk of downturns in demand for products using
synthetic biology, (v) the uncertainty regarding the demand for
passive monitoring programs and biosecurity services, (vi) changes
to the biosecurity industry, including due to advancements in
technology, emerging competition and evolution in industry demands,
standards and regulations, (vii) the outcome of any pending or
potential legal proceedings against Ginkgo, (viii) our ability to
realize the expected benefits from and the success of our Foundry
platform programs and Codebase assets, (ix) our ability to
successfully develop engineered cells, bioprocesses, data packages
or other deliverables, (x) the product development, production or
manufacturing success of our customers, (xi) our exposure to the
volatility and liquidity risks inherent in holding equity interests
in other operating companies and other non-cash consideration we
may receive for our services, (xii) the potential negative impact
on our business of our restructuring or the failure to realize the
anticipated savings associated therewith and (xiii) the uncertainty
regarding government budgetary priorities and funding allocated to
government agencies. The foregoing list of factors is not
exhaustive. You should carefully consider the foregoing factors and
the other risks and uncertainties described in the "Risk Factors"
section of Ginkgo's annual report on Form 10-K filed with the U.S.
Securities and Exchange Commission (the "SEC") on February 25, 2025 and other documents filed by
Ginkgo from time to time with the SEC. These filings identify and
address other important risks and uncertainties that could cause
actual events and results to differ materially from those contained
in the forward-looking statements. Forward-looking statements speak
only as of the date they are made. Readers are cautioned not to put
undue reliance on forward-looking statements, and Ginkgo assumes no
obligation and does not intend to update or revise these
forward-looking statements, whether as a result of new information,
future events, or otherwise. Ginkgo does not give any assurance
that it will achieve its expectations.
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