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    Analysis

    Why biomanufacturing still fails at scale-up

    The limiting factor in biomanufacturing is no longer strain design but the step between laboratory and factory: the United States is reported to lack pilot- and demonstration-scale fermentation capacity.[1][2] Public money is now building shared tankage while the best-known platform company has halved its workforce, which makes 2026 a test of whether capacity or business model was the real constraint.[3][4]

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    The evidence

    The United States is reported to be severely short of pilot- and demonstration-scale equipment for precision fermentation, which is the stated reason for federal investment in bioindustrial pilot plants.[1] BioMADE says the shortage forces American companies to seek facilities overseas, taking American innovation with them and risking loss of intellectual property.[2] Its chief executive frames the problem as missing assets rather than missing science.[5]

    The public response is concrete. A $132 million, 122,000-square-foot demonstration facility with two 25,000-litre fermenters was finalised in Maple Grove, Minnesota on 29 April 2025.[3] BioMADE’s own releases describe a nearly 25,000-square-foot pilot site in Hayward, California with aerated stirred tanks of up to 4,000 litres, in a project worth at least $80 million that it aimed to open to customers in early 2026.[6] A 15,000-square-foot Iowa site near Ames, built with Iowa State University, has 5,000 and 10,000-litre fermenters in a $40 million project.[7] Its stated opening date has moved: an August 2025 release said early 2028, a November 2025 groundbreaking release said 2027.[8] The Department of Defense had provided about $87 million at inception and $450 million in 2023.[9] A congressionally created commission recommended at least $15 billion of US investment in April 2025.[10][11]

    Company results point the other way on demand. Ginkgo Bioworks reported revenue of $20.2 million and a net loss of $46.7 million for the quarter ended 30 June 2026, after workforce reductions of more than 50% substantially concluded by 31 December 2025.[12][4] Government and defence customers made up 45% of its second-quarter revenue.[13] Suppliers, by contrast, grew: Twist Bioscience reported record revenue of $118.4 million for the quarter to June 2026 and raised full-year guidance to $456 million to $457 million.[14][15]

    What the facts suggest

    The two bodies of evidence are not contradictory, but they point to different bottlenecks. The capacity story is a supply-side explanation: good products exist but cannot be made at intermediate scale, so a public good is missing. The company results are a demand-side explanation: engineering organisms to order has not generated enough paying volume to sustain a platform, which is why Ginkgo cut more than half its staff and now leans on government and defence work for nearly half its revenue.[4][13]

    The supplier pattern is the strongest single signal. If engineering biology were constrained purely by tankage, service businesses would still show a backlog of customers waiting for capacity. Instead the growth is in inputs: DNA volumes rose from about 237,000 to about 369,000 genes per quarter at one provider.[16] That is consistent with a field doing a great deal of research and relatively little commodity production.

    Where capacity clearly binds is food and materials, where a product must be demonstrated at tonne scale before anyone will buy it. There the regulatory gate also has to be cleared, as with the September 2025 no-questions letter on fermented egg protein.[17]

    What may happen next

    Expect the capacity question to be answered empirically within about two years, because the plants have dates. BioMADE aimed to open Hayward to customers in early 2026, and its published Iowa date has moved between 2027 and early 2028, so utilisation figures and tech-transfer times from BioMADE‘s network are the measurable test of the supply-side thesis.[6][8] If those tanks fill and products graduate to commercial volumes, capacity was the constraint; if they sit partly idle, the problem was never the tanks.

    For service companies, the near-term path visible in the filings is narrower and more government-funded: a single reportable segment, automation hardware and defence contracts.[18][13] That makes public procurement, rather than commercial adoption, the main variable for revenue over the next several quarters. Uncertainty is high in both directions: BioMADE publishes each site’s size, cost and target opening date, but not utilisation or contract pipelines.[6][7]

    What would change the picture

    Published utilisation data from shared plants, a commercial-scale product that moved from a BioMADE site to a dedicated factory, or a return to growth in organism-engineering services revenue would each resolve part of the disagreement.[3][12] The field’s input suppliers will keep reporting quarterly volumes, which is the cheapest available proxy for overall activity.[16]

    Competing views

    Capacity is the binding constraint

    Designs work; there is nowhere to run them at 4,000 to 25,000 litres, so public plants unblock a real queue.[1][2][3]

    Unit economics are the binding constraint

    Tanks do not fix cost of goods. Ginkgo's halved workforce and $20.2 million quarter suggest demand, not capacity, was missing.[12][4][13]

    Tools, not products, are where value accrues

    DNA and instrument suppliers grow while organism-engineering services shrink, implying the durable business is inputs.[14][15][12]

    Questions readers ask

    What exactly is the scale-up gap?

    A shortage of pilot- and demonstration-scale fermentation capacity. BioMADE says it pushes American companies to facilities overseas, taking innovation with them and risking loss of intellectual property.[1][2]

    How much public money is going into capacity?

    BioMADE finalised $132 million for a Minnesota demonstration plant in April 2025, after about $87 million at inception and $450 million directed by the Department of Defense in 2023.[3][9]

    Is the platform model working commercially?

    Not on current numbers. Ginkgo Bioworks reported $20.2 million of revenue and a $46.7 million net loss for the quarter to June 2026 after cutting more than half its workforce.[12][4]

    Which parts of the sector are growing?

    Suppliers. Twist Bioscience reported record revenue of $118.4 million in the quarter to June 2026 and raised full-year guidance to about $456-457 million.[14][15]

    Sources

    Each numbered claim is a statement we checked against the sources listed with it. Status shows how well established it is.

    1. [1]

      The United States is reported to be severely short of pilot- and demonstration-scale equipment for precision fermentation, which is the stated reason for federal investment in bioindustrial pilot plants. reportedas of 2026-05-11

    2. [2]

      BioMADE says the shortage of pilot- to demonstration-scale capacity forces American companies to use facilities overseas, taking innovation with them and risking loss of intellectual property. confirmedas of 2025-04-29

    3. [3]

      On 29 April 2025 BioMADE finalised a $132 million investment, funded by the US Department of Defense and Minnesota's economic development department, in a 122,000-square-foot demonstration-scale biomanufacturing facility in Maple Grove, Minnesota with two 25,000-litre industrial fermenters. confirmedas of 2025-04-29

    4. [4]

      Ginkgo Bioworks cut more than half its workforce in a restructuring that was substantially concluded by 31 December 2025, with facility consolidation continuing through 2026. confirmedas of 2026-06-30

    5. [5]

      BioMADE's chief executive said the United States has led biotechnology research for more than 40 years but needs additional assets to bring innovations from the laboratory to commercial production. confirmedas of 2025-04-29

    6. [6]

      BioMADE's California pilot plant in Hayward is a nearly 25,000-square-foot multi-user facility with aerated stirred tanks of up to 4,000 litres, in a project worth at least $80 million funded by the US Department of Defense; BioMADE said in April 2025 that it aimed to open it to customers in early 2026. confirmedas of 2025-04-30

    7. [7]

      BioMADE's Iowa pilot plant, built near Ames with Iowa State University, is a 15,000-square-foot multi-user site with 5,000 and 10,000-litre industrial fermenters, in a $40 million project to which BioMADE committed at least $20 million, matched by up to $10 million from the university and $10 million from a state infrastructure programme. confirmedas of 2025-11-14

    8. [8]

      BioMADE's stated opening date for the Iowa pilot plant has moved. An August 2025 release said the site was set to open in early 2028, while the November 2025 groundbreaking release said it was scheduled to open in 2027. disputedas of 2025-11-14

    9. [9]

      The US Department of Defense gave BioMADE about $87 million at its inception and directed a further $450 million to it in 2023. reportedas of 2026-05-11

    10. [10]

      The National Security Commission on Emerging Biotechnology, a bipartisan body created by the fiscal 2022 National Defense Authorization Act, delivered its final report "Charting the Future of Biotechnology" to Congress in April 2025 with 49 recommendations. confirmedas of 2025-04-30

    11. [11]

      The commission's headline recommendation is at least $15 billion of US government investment to grow biotechnology innovation and biomanufacturing. confirmedas of 2025-04-30

    12. [12]

      Ginkgo Bioworks reported total revenue of $20.2 million and a net loss of $46.7 million for the quarter ended 30 June 2026. confirmedas of 2026-06-30

    13. [13]

      Government and defence customers accounted for 45% of Ginkgo Bioworks' revenue in the second quarter of 2026 and 41% in the first half, its largest customer group. confirmedas of 2026-06-30

    14. [14]

      Twist Bioscience reported record revenue of $118.4 million for the third quarter of fiscal 2026, more than 23% above the $96.1 million of the same quarter a year earlier. confirmedas of 2026-08-05

    15. [15]

      Twist Bioscience raised its fiscal 2026 revenue expectation to $456 million to $457 million, about 21% year-on-year growth. confirmedas of 2026-08-05

    16. [16]

      Twist Bioscience shipped about 369,000 synthetic genes in the third quarter of fiscal 2026, against about 237,000 in the same quarter of fiscal 2025. confirmedas of 2026-08-05

    17. [17]

      On 24 September 2025 Onego Bio said the US Food and Drug Administration had issued a "no questions" letter on the GRAS status of its Bioalbumen egg protein, filed as GRAS Notice GRN 1249. confirmedas of 2025-09-24

    18. [18]

      After divesting its biosecurity business in April 2026, Ginkgo Bioworks reports as a single segment covering biological research services and tools. confirmedas of 2026-06-30

    Revision history (2)
    1. Page created.
    2. Refresh: replaced the May 2026 press summary of the pilot-plant build-out with BioMADE's own releases, recorded the Iowa opening-date conflict and added the April 2026 project awards.

    Created Oct 10, 2026. Last reviewed by an editor on Oct 10, 2026. Next scheduled review: Jan 10, 2027.

    Cite this page

    "Why biomanufacturing still fails at scale-up." ContentLora, updated Oct 10, 2026. https://contentlora.com/analysis/biomanufacturing-scale-up-debate

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