Lesson 7 — Who Does What? Why? Who Pays?

Understanding the Complex: What Is Synthetic Biology?

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In 2009, Jason Kelly and Barry Canton — both MIT synthetic biology alumni — founded Ginkgo Bioworks in Boston. The idea was unusual: instead of developing their own products, they would build biological "programs" for other companies. A pharmaceutical company that needed an organism to produce a compound. A fragrance company that wanted a particular aromatic molecule. An agricultural company looking for a microbial soil amendment.

Ginkgo called itself a "foundry" — a reference to semiconductor foundries like TSMC, which manufacture chips designed by other companies. The analogy was deliberate. Ginkgo would industrialize the design-build-test-learn cycle, running thousands of experiments in automated facilities, building up a library of biological programs, and licensing them to clients.

By the early 2020s, Ginkgo had become one of the most visible companies in the field — and one of the most controversial. Critics argued that its valuation ($15 billion at its 2021 public listing) outran its demonstrated revenues. Supporters argued that foundry models take time to mature, pointing to how long it took semiconductor foundries to establish their business model.

Whatever the verdict on Ginkgo specifically, the foundry model points to something real: the industrialization of synthetic biology. The question is not whether biological engineering will be scaled, but how, by whom, and at what cost.

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The academic landscape. The major research universities — MIT, Stanford, UC Berkeley, Harvard, Imperial College London, ETH Zurich — contain the field's intellectual foundations. Drew Endy is at Stanford. George Church, whose lab has worked on everything from reading ancient mammoth DNA to engineering pig organs for human transplant, is at Harvard. Jay Keasling holds appointments at Berkeley and the Lawrence Berkeley National Laboratory.

Academic labs do the basic science: developing new tools (CRISPR, better gene synthesis methods, new chassis organisms), characterizing biological parts, publishing findings that others can build on. Academic research is largely funded by government agencies: the National Science Foundation (NSF) and National Institutes of Health (NIH) in the US; the European Research Council (ERC) and national funders in Europe; national research councils worldwide.

DARPA — the Defense Advanced Research Projects Agency — has played an unusual role. Its Biological Technologies Office has funded projects specifically aimed at accelerating the timeline from concept to deployable biological capability, including work on rapid vaccine development, biosensors for battlefield environments, and — controversially — research programs that touch on the dual-use concerns discussed in Lesson 6.

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The startup ecosystem. Between academic labs and large companies sits a growing layer of startups. Some focus on specific applications: Pivot Bio (agricultural biostimulants), Modern Meadow (bioleather), LanzaTech (gas fermentation for chemicals and fuels). Others, like Ginkgo, focus on platform capabilities. Still others build tools: Twist Bioscience, which makes custom DNA at scale; Benchling, which makes laboratory information management software; Zymergen (acquired by Ginkgo in 2021).

Venture capital has flowed into this space significantly since 2015. Estimates vary, but synthetic biology startups raised several billion dollars per year at the peak of the investment cycle in 2020–2022. That flow has slowed somewhat as broader tech investment cooled, but the sector remains active.

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The large company dimension. Established players in agriculture (Bayer, Corteva, BASF), chemicals (DSM-Firmenich, Evonik), and pharmaceuticals (most major biopharma companies) have either acquired synthetic biology capabilities, partnered with startups, or built internal programs. The motivation is clear: if biological manufacturing becomes competitive with petrochemical synthesis, companies that have not built that capability will be at a disadvantage.

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Regulation. Regulatory oversight varies enormously by country and application.

In the United States, oversight is distributed across multiple agencies: the FDA (food and drugs), the EPA (environmental applications, including genetically modified organisms released into the environment), the USDA (agricultural applications). The framework was established in the 1980s for first-generation GMOs and has been adapted patchwork-style to synthetic biology — with some gaps.

In the European Union, the GMO regulatory framework is stricter. Genetically modified organisms (GMOs) intended for environmental release or food use require extensive safety assessments before approval, and the precautionary principle is applied more aggressively than in the US. This has slowed the introduction of some products in Europe while they moved forward in the US or elsewhere.

International coordination is limited. There is no global regulatory body for synthetic biology, and national frameworks differ enough that a product approved in one jurisdiction may not be approvable in another. This is both a challenge for companies operating globally and a governance gap that the field has not yet fully addressed.

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Next lesson: What's Contested? What Don't We Know? — the genuinely hard debates in synthetic biology.

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Reading time: approx. 9–10 minutes