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.
(PRNewsfoto/Ginkgo Bioworks)
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.
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.
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.
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.
