Ginkgo Bioworks Joins ARPA-H GIVE Program to Build Autonomous Manufacturing System for Individualized RNA Medicines

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Ginkgo plans to build the automation hardware and control software for ESCALATOR, a continuous-flow, autonomous manufacturing system designed to produce and quality-release RNA drug products at patient scale

BOSTON--(BUSINESS WIRE)-- Ginkgo Bioworks (NYSE: DNA) today announced that it has been awarded a subcontract for up to $17.5M under the Advanced Research Projects Agency for Health’s (ARPA-H) Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program. Ginkgo will serve as a subcontractor to prime contractor Waterfall Scientific, Inc. on ESCALATOR (Engineering a Small-scale, Continuous-flow manufacturing Apparatus to Launch A Transformational Overhaul for RNA medicines), a multi-organization effort to compress end-to-end RNA drug manufacturing onto a benchtop footprint.

RNA therapeutics designed for a single patient—including individualized cancer vaccines and bespoke gene therapies—remain difficult to deliver at scale. Production today depends on large, centralized facilities, lengthy manual workflows, and quality control processes that were designed for batch sizes far larger than one. The result is a class of medicine that is scientifically feasible but logistically out of reach for most patients who could benefit from it.

ESCALATOR is designed to change that equation by building a single, integrated, autonomous manufacturing system that accepts a sequence and returns a purified, quality-released RNA drug product at the scale an individual patient requires. The system comprises four custom manufacturing modules: cell-free DNA template production, RNA synthesis, lipid nanoparticle (LNP) encapsulation, and fill and finish. These are coupled to an in-line quality control subsystem drawing on approximately twenty analytical instruments.

Ginkgo’s Role: Making Twenty Instruments Behave as One System

Ginkgo is building the layer that turns a collection of instruments into an integrated autonomous manufacturing system and carries the process through to an automated quality decision on the finished product. Drawing on its Reconfigurable Automation Carts (RACs) and Catalyst software, Ginkgo aims to:

• Integrate the four custom manufacturing modules and the quality control instrument set into a unified robotic transport platform;
• Extend Catalyst to control the entire system with a unified interface, providing simple local configuration and launching of manufacturing runs, remote protocol definition and monitoring, and the data integrity and audit trail expected of GMP manufacturing environments;
• Develop and validate automated protocols for both the manufacturing and quality control workflows, including virtual protocol simulation prior to hardware execution; and
• Enable Catalyst to rigorously evaluate product quality based on data collected by the system and historical benchmarks, escalating to expert review as appropriate.

“One of the most challenging parts of ESCALATOR is making instruments from six different organizations behave as one controlled, auditable system that a trained technician can operate without a robotics team standing behind them,” said Jason Kelly, co-founder and CEO at Ginkgo Bioworks. "Ginkgo has spent years building autonomous labs that can work with a variety of hardware and with proprietary software that tracks every device for every run. Distributed manufacturing has stayed a promise rather than a practice because that layer didn’t exist. We are excited to be deploying it for ESCALATOR.”

"We are thrilled to lead such an exceptional consortium on this journey to make personalized medicine a reality for patients who cannot wait. Ginkgo Bioworks brings unmatched hardware and software integration capabilities to the table, and we look forward to building a truly transformative system together,” said Inna Shcherbakova, co-founder and CEO of Waterfall Scientific.

A Consortium Assembled Around a Single Integrated System

The ESCALATOR team brings together six organizations across the United States and Canada:

• Waterfall Scientific (Worcester, MA): prime contractor; continuous-flow RNA synthesis based on its DuoTether™ platform
• Ginkgo Bioworks (Boston, MA, and Emeryville, CA): automation hardware, systems integration, and control software
• Ansa Biotechnologies (Emeryville, CA): enzymatic, cell-free DNA template production
• Polymorphic Biosciences (Vancouver, BC): lipid nanoparticle (LNP) encapsulation
• Tensentric (Boulder, CO): fill and finish, sterility, and device engineering
• Volta Labs (Boston, MA): automation and miniaturization for DNA template production and characterization

GIVE is administered by ARPA-H’s Scalable Solutions Office, which funds programs intended to improve the speed, scale, and accessibility of medical treatments across the United States. The program is structured in phases, beginning with a design and engineering phase, followed by build, integration, and system demonstration. Work is expected to begin with a technical kickoff later this month.

Building on a Growing Federal Portfolio

ESCALATOR extends Ginkgo’s work with ARPA-H and other federal partners on programs aimed at national health resilience. A small business under many federal size standards, Ginkgo both contributes platform-scale automation, software, and biological engineering as a subcontractor to consortia led by specialized innovators, and leads consortia as prime contractor with our growing systems integration and Government relations experience; ESCALATOR represents the former model. Our U.S. Government research portfolio demonstrates how federal funds can enable highly focused and innovative technology companies to access infrastructure they would otherwise need years to build.

About Ginkgo Bioworks

Ginkgo Bioworks builds the tools that make biology easier to engineer for everyone. The company offers autonomous laboratories that replace manual laboratory work with robotics in the lab, greatly improving the productivity of scientists. Ginkgo's in-house autonomous lab is also available as a "Cloud Lab" through our Datapoints and Solutions contract research services. For more information, visit ginkgobioworks.com, read our blog, or follow us on social media channels such as X (@Ginkgo), Instagram (@GinkgoBioworks), Threads (@GinkgoBioworks), or LinkedIn.

About Waterfall Scientific

Waterfall Scientific is a Massachusetts-based biotechnology platform company developing continuous-flow technologies for mRNA manufacturing. Spun out of the University of Massachusetts Amherst with exclusively licensed technology developed in the laboratory of Prof. Craig T. Martin, Ph.D, (Waterfall Scientific CSO and Co-founder), Waterfall Scientific’s DuoTether continuous-flow system dramatically improves the purity and efficiency of mRNA synthesis. Waterfall welcomes interest from investors in the biomanufacturing space. For more information, visit www.waterfallsci.com.

Forward-Looking Statements of Ginkgo Bioworks

This announcement contains certain forward-looking statements within the meaning of the federal securities laws, including statements regarding the capabilities and potential success of the partnership. 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 announcement, 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 platform programs and 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, (xiii) the uncertainty regarding government budgetary priorities and funding allocated to government agencies, including potential adverse effects from the U.S. government shutdown, (xiv) our ability to scale, expand the capacity of, and continue to develop the capabilities of our autonomous lab (including Nebula) on the timelines and to the extent we anticipate, (xv) the pace and degree to which autonomous laboratory infrastructure is adopted by, and displaces manual laboratory work in, the broader life sciences and industrial biotechnology markets, (xvi) the actual size, composition and growth of the addressable markets we target, which may differ materially from our estimates, (xvii) our ability to integrate our autonomous lab platform with third-party artificial intelligence models and other technologies, and the rate of development and adoption of such technologies, and (xviii) our ability to maintain and expand strategic partnerships and customer relationships, including those with named partners referenced in this announcement. 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 26, 2026, 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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MEDIA CONTACT: press@ginkgobioworks.com

INVESTOR CONTACT: investors@ginkgobioworks.com

Source: Ginkgo Bioworks

Key Terms

cell-free dna technical

Fragments of DNA that float freely in the bloodstream after being released by dying or damaged cells, like puzzle pieces carried downstream that hint at what’s happening upstream. Investors care because measuring these fragments enables non‑invasive tests — for example to detect cancer, monitor treatment response, check pregnancy health, or spot organ rejection — so advances, approvals, or reimbursement changes can quickly affect companies that develop the tests and related technologies.

lipid nanoparticle medical

A lipid nanoparticle is a tiny, fat‑based microscopic shell that carries and protects delicate molecules (like RNA or drugs) and helps them enter cells, similar to a microscopic delivery bubble. It matters to investors because this delivery method can make new therapies and vaccines possible or more effective, but also affects manufacturing complexity, scalability, regulatory review and cost — all of which influence a biotech company’s commercial prospects.

fill and finish technical

The final stage of producing biological medicines where bulk drug substance is transferred into final dosage forms—filling vials, syringes, or cartridges—and then sealed, labeled and packaged for distribution. It matters to investors because this step determines how quickly a treatment can reach patients, creates manufacturing bottlenecks or capacity value, and often involves specialized facilities and regulatory controls; think of it as the bottling and labeling line in a beverage plant that readies product for sale.

gmp regulatory

Good Manufacturing Practice (GMP) is a set of regulatory standards and procedures that ensure products—especially medicines, medical devices, and related goods—are consistently made to meet safety, quality, and purity requirements. For investors, GMP compliance is like a factory’s hygiene and checklist system: it reduces the risk of product recalls, regulatory fines, and production stoppages, supports market access, and signals more reliable, lower-risk operations that can protect revenue and reputation.