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    How biomanufacturing works

    Biomanufacturing grows an engineered organism in a tank and purifies what it makes, scaling from litres in the laboratory to tens of thousands of litres in production.[1] The engineering is no longer the hardest step: the United States is reported to lack pilot- and demonstration-scale capacity, and federal money is now going into shared plants to close that gap.[2][3]

    Editor reviewedUpdated Synthetic biologyLife sciencesScience

    The production chain

    Biomanufacturing is farming at microbial scale. You put an engineered microbe or cell line in a tank with sugar or another feedstock, keep the temperature, oxygen and pH where the organism likes them, and let it make the molecule you want. Then you separate the product from the cells and the broth, purify it, and test it.[4]

    Scale matters because nothing behaves the same way in a big tank. Mixing, oxygen transfer and heat removal all get harder, so a strain that performs well in a flask may underperform in 25,000 litres.[1] Companies therefore step up gradually: bench, then pilot tanks of a few thousand litres, then demonstration vessels of tens of thousands of litres.[5][6][1]

    The chain is strain construction, fermentation process development, downstream processing and quality release. Each stage has its own failure mode: metabolic burden and genetic instability upstream; oxygen transfer, shear and mixing-time limits as vessel volume rises; and recovery yield and impurity profile downstream, which commonly dominate cost of goods for secreted proteins.

    Host choice encodes most of those trade-offs. Filamentous fungi such as Trichoderma reesei are used for secreted food proteins because the industry already knows how to run them at scale; Onego Bio’s ovalbumin is made that way.[4] Where product demand is small, variable or location-dependent, cell-free expression becomes attractive since there is no growth phase and reactions can be started and stopped.[7][8]

    Where the bottleneck actually is

    In 2026 the constraint is not design but tankage. The United States is reported to be severely short of pilot- and demonstration-scale precision fermentation equipment, which is the stated justification for federal investment in shared plants.[2] BioMADE, a Manufacturing USA institute, says the gap pushes American companies to use overseas facilities, taking innovation with them and risking loss of intellectual property.[9][3]

    The money is specific. BioMADE finalised a $132 million, 122,000-square-foot demonstration facility in Maple Grove, Minnesota with two 25,000-litre fermenters in April 2025.[1] Its Hayward, California pilot site is nearly 25,000 square feet with tanks of up to 4,000 litres, in an at-least-$80-million project it aimed to open to customers in early 2026, and its 15,000-square-foot Iowa site has 5,000 and 10,000-litre fermenters in a $40 million project.[5][6] The Department of Defense had already provided about $87 million at inception and $450 million in 2023.[10]

    Regulatory gate

    For food and feed products in the United States, the practical approval step is a GRAS notification: Onego Bio announced in September 2025 that the Food and Drug Administration had no questions about the GRAS status of its fermented egg protein, filed as GRN 1249.[11] Regulatory timing often sets launch dates more than process readiness does.

    Why governments care

    A congressionally created commission reported in April 2025 with 49 recommendations and a headline call for at least $15 billion of US investment in biotechnology innovation and biomanufacturing.[12][13] Procurement follows the same logic from the demand side: government and defence customers supplied 45% of Ginkgo Bioworks’ revenue in the second quarter of 2026.[14]

    Questions readers ask

    What scale counts as production?

    BioMADE's demonstration-scale Minnesota facility runs two 25,000-litre industrial fermenters; its Hayward pilot site uses 4,000-litre tanks.[1][5][6]

    Why do companies struggle to scale up?

    BioMADE says the shortage of pilot- to demonstration-scale capacity pushes American companies to use overseas facilities, taking innovation with them and risking loss of intellectual property.[3]

    Does biomanufacturing always need living cells?

    No. Cell-free systems express proteins in a tube using extracted machinery, reaching about 4 milligrams per millilitre in batch reactions.[7][8]

    Who is funding capacity in the United States?

    The Department of Defense gave BioMADE about $87 million at inception and directed a further $450 million in 2023; a congressional commission recommended at least $15 billion for biotechnology and biomanufacturing.[10][13]

    Sources

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

    1. [1]

      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

    2. [2]

      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

    3. [3]

      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

    4. [4]

      Onego Bio's Bioalbumen is ovalbumin with the same amino acid sequence as chicken egg white protein, made by precision fermentation in the filamentous fungus Trichoderma reesei. confirmedas of 2025-09-24

    5. [5]

      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

    6. [6]

      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

    7. [7]

      Cell-free transcription-translation (TXTL) systems express genes in a tube using extracted cellular machinery, and are used to test genetic regulatory elements and circuits without living cells. confirmedas of 2021-08-04

    8. [8]

      The all-E. coli TXTL toolbox 3.0 reported protein synthesis of 4 milligrams per millilitre in batch reactions and more than 8 milligrams per millilitre inside synthetic cell compartments. confirmedas of 2021-08-04

    9. [9]

      BioMADE is a Manufacturing USA institute for bioindustrial manufacturing that works to build national infrastructure for taking biotechnology from laboratory scale to commercial production. confirmedas of 2025-04-29

    10. [10]

      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

    11. [11]

      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

    12. [12]

      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

    13. [13]

      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

    14. [14]

      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

    Revision history (2)
    1. Page created.
    2. Refresh: re-sourced the pilot and demonstration plant figures to BioMADE's own releases for Hayward, Iowa and Minnesota.

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

    Cite this page

    "How biomanufacturing works." ContentLora, updated Oct 10, 2026. https://contentlora.com/explain/how-biomanufacturing-works

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