Ginkgo Bioworks Awarded DARPA Contract to Reimagine the Manufacturing of Complex Therapeutic Proteins

ARLINGTON, Va. and BOSTON, July 19, 2023 /PRNewswire/ -- Approved for Public Release, Distribution Unlimited — The Defense Advanced Research Projects Agency (DARPA) announced that Ginkgo Bioworks (NYSE: DNA), which is building the leading platform for cell programming and biosecurity, has been awarded a 4-year contract worth up to $18 million to reimagine how to manufacture complex therapeutic proteins. As a performer on DARPA's Reimagining Protein Manufacturing (RPM) project, Ginkgo aims to deliver revolutionary advances in on-demand protein manufacturing by leveraging Cell-Free Protein Synthesis (CFPS) to enable rapid, high-yield, distributed production of human therapeutic proteins that support national security objectives. Ginkgo will lead a team comprising representatives from Imperial College London, led by Prof. Paul Freemont, Nature's Toolbox, Inc., led by Alex Koglin, and consultant Michael Feldhaus (former Executive VP of Antibody Discovery at Adimab).

"There is growing recognition that pharmaceutical supply chains are at risk. One way to meet this challenge is distributed manufacturing at the point of care," said Jason Kelly, CEO and co-founder of Ginkgo Bioworks. "Imagine a future where drugs, including complex biologics, are produced locally or in a widely distributed manner on-demand. We're very excited to be working with DARPA to make that future a reality."

Therapeutic proteins bearing so-called "post-translational modifications," such as antibodies, cytokines, and clotting factors are particularly important in the marketplace and to DARPA, as are subunit and conjugate vaccines. Half of the top-selling drugs used to treat cancer and autoimmune diseases are such therapeutic proteins; many are also used as medical countermeasures to treat or prevent disease, injury, or death related to chemical, biological, radiological, or nuclear threats. Through this program, Ginkgo hopes to transform how therapeutic proteins are made, replacing cell-based methods with cell-free methods. Traditional centralized, large-scale manufacturing methods have usually sufficed, but increasingly there are use cases where rapid distributed or on-demand manufacturing is needed, such as supplying of therapeutic proteins to geographically isolated locales, providing hospitals and clinics with point-of-need rapid production of medicines from common precursors, and improving our ability to mount rapid and targeted responses to natural or man-made biological threats and emergencies.

Traditional production methods rely on weeks- to months-long construction of bespoke cellular organisms that have been engineered to produce the desired therapeutic protein during days-long fermentation processes. Even with standardized methods, it typically takes months to achieve the first useful production of a biological drug. Post-expression isolation and purification are equally challenging: each unique process is costly and time-consuming to develop.

Cell-Free Protein Synthesis (CFPS), by contrast, brings the key advantages of greater speed and flexibility than cell- and fermentation-based production. Significant improvements are needed to make CFPS competitive with traditional therapeutic protein production, however, primarily with respect to efficiency and the identity and homogeneity of post-translational modifications. In this program, Ginkgo seeks to address these challenges and hopes to enable the rapid prototyping of enzymes and other proteins for diverse therapeutic and nontherapeutic projects. One aim of the project is to create production methods that are compatible with Good Manufacturing Practices, thereby facilitating adoption by the pharmaceutical industry.

Ginkgo will leverage innovative technologies enabled by its high-throughput, automated Foundry and its proprietary genetic data Codebase, a portfolio of reusable biological assets which includes more than one billion proprietary gene sequences. Ginkgo's synthetic biology platform, coupled with its extensive expertise in iterative Design–Build–Test–Learn-driven biological engineering, enables the rapid prototyping, optimization, and development of proteins, enzymes, metabolic pathways, and whole organisms under commercial-scale manufacturing conditions processes.

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's biosecurity and public health unit, Concentric by Ginkgo, is building global infrastructure for biosecurity to empower governments, communities, and public health leaders to prevent, detect and respond to a wide variety of biological threats. For more information, visit ginkgobioworks.com and concentricbyginkgo.com, read our blog, or follow us on social media channels such as Twitter (@Ginkgo and @ConcentricByGBW), Instagram (@GinkgoBioworks and @ConcentricByGinkgo), or LinkedIn.

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 contract 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) 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, (ii) the ability to implement business plans, forecasts, and other expectations, and to identify and realize additional business opportunities, (iii) the risk of downturns in demand for products using synthetic biology, (iv) the unpredictability of the duration of the COVID-19 pandemic and the demand for COVID-19 testing and the commercial viability of our COVID-19 testing business, (v) changes to the biosecurity industry, including due to advancements in technology, emerging competition and evolution in industry demands, standards and regulations, (vi) our ability to realize the expected benefits of merger and acquisition transactions, (vii) the outcome of any legal proceedings against Ginkgo, including as a result of recent acquisitions, (viii) our ability to realize the expected benefits from and the success of our Foundry platform programs, (ix) our ability to successfully develop engineered cells, bioprocesses, data packages or other deliverables, and (x) the product development or commercialization success of our customers. 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 quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission (the "SEC") on May 10, 2023 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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SOURCE Ginkgo Bioworks