Biomanufacturing

The capacity to make with biology: fermentation, cell and gene production platforms, vaccine and biologics manufacture, and the bioprocess technology that turns biological designs into supply.
Hard Power / Critical Technology / Biotechnology & Health Technologies

The capacity to make with biology: fermentation, cell and gene production platforms, vaccine and biologics manufacture, and the bioprocess technology that turns biological designs into supply.

Indicators

  • Biologics manufacturing capacity
  • Vaccine production capacity
  • Fermentation capacity installed
Capability Developments

Major milestones and key developments of the capability

The Capability Development Index tracks the events that move a capability — operational use, technical breakthroughs, procurement decisions and the industrial base behind them — and places each on the record with the date it happened.

Recent developments cover the current period. Historical developments are the inflection points that produced Biomanufacturing as it stands today.

GeopoliticalGovernanceTechnologyEconomySociety

Historical Developments

c. 7000 BCEVillagers at Jiahu in China produced the earliest known fermented beverage about 9,000 years ago

Residues in pottery from the Yellow River valley show a drink made from rice, honey and fruit, evidence that using living organisms to manufacture a consumable product is a Neolithic technology.

1919Pfizer opened the first industrial fermentation plant for citric acid 107 years ago

Using the mould Aspergillus niger, the process ended reliance on imported Italian citrus for citric acid and became the model for large-scale industrial fermentation of organic acids and, later, antibiotics.

1943US pharmaceutical manufacturers scaled penicillin production using deep-tank fermentation 83 years ago

Submerged fermentation in large steel tanks, developed under wartime pressure, turned penicillin from a scarce laboratory extract into a mass-produced drug, establishing industrial fermentation methods still used for antibiotics.

1956Japanese researchers discovered a bacterium that made industrial amino acid fermentation possible 70 years ago

Kyowa Hakko scientists isolated Corynebacterium glutamicum, enabling low-cost microbial production of glutamate and later lysine, and establishing Japan as a founder of the modern industrial fermentation industry.

1957Theodore Puck derived the Chinese hamster ovary cell line 69 years ago

The cell line isolated at the University of Colorado became the standard host for manufacturing complex biologic drugs, and CHO cells are still used to produce most therapeutic antibodies today.

1973Herbert Boyer and Stanley Cohen demonstrated recombinant DNA technology 53 years ago

Splicing foreign DNA into bacteria and having it replicate gave biomanufacturing its foundational tool, turning microorganisms into programmable production hosts for proteins they do not naturally make.

1975Georges Köhler and César Milstein invented the hybridoma technique for producing monoclonal antibodies 51 years ago

Fusing antibody-producing cells with myeloma cells created a way to manufacture a single, uniform antibody indefinitely, the basis of the monoclonal antibody industry that now dominates biologic drug sales.

1982Genentech and Eli Lilly brought the first recombinant biologic drug to market 44 years ago

Humulin, human insulin manufactured by genetically engineered bacteria, replaced insulin extracted from animal pancreases and proved that engineered microorganisms could manufacture a protein drug at commercial scale.

1995China became the world's largest producer of fermentation-derived antibiotics and bulk drug ingredients 31 years ago

State-linked and private manufacturers built vast fermentation capacity for penicillin, vitamin and amino acid intermediates, making China the dominant global supplier of bulk pharmaceutical ingredients still relied on today.

2004NCBioImpact was established as a state-wide biomanufacturing training network 22 years ago

NCBioImpact was set up in 2004 as a comprehensive state-wide training network for biomanufacturing skills. Such workforce initiatives matter because biomanufacturing depends on personnel trained in the specialised equipment and cell-culture techniques used to grow microbes, animal cells and plant cells.

2020mRNA vaccine manufacturers scaled a new biomanufacturing platform to billions of doses 6 years ago

Pfizer-BioNTech and Moderna took lipid-nanoparticle mRNA production from laboratory scale to billions of doses within a year, establishing a manufacturing platform now being adapted for other diseases.

The WHO launched a technology transfer hub in South Africa to spread mRNA manufacturing know-how

Recent Developments

October 2025China named biomanufacturing a strategic pillar for its next five-year plan 10 months ago

Proposals discussed at the Communist Party's autumn plenum set biomanufacturing alongside other frontier sectors as a priority for the 2026 to 2030 planning period, continuing state support for fermentation and cell-culture capacity.

Shenzhen had already passed China's first dedicated biomanufacturing regulation
April 2025Samsung Biologics brought its largest single biologics plant toward full operation last year

Plant 5 at the company's Songdo bio campus added large-scale mammalian cell-culture capacity, reinforcing South Korea's position as host to the world's biggest contract biologics manufacturer by volume.

2025Fiocruz began domestic production of mRNA vaccine antigen last year

Brazil's Bio-Manguinhos institute, using technology licensed through the WHO mRNA hub network, produced its first batches of locally made mRNA vaccine antigen, part of a wider Latin American push for manufacturing independence.

2025Afrigen Biologics took its self-developed mRNA vaccine into human trials last year

The Cape Town firm, hub of the WHO-backed mRNA technology transfer programme, moved its reverse-engineered COVID-19 vaccine candidate into a Phase 1 trial, a step toward African vaccine manufacturing self-sufficiency.

2025WuXi Biologics expanded manufacturing outside China as US restrictions loomed last year

Facing possible exclusion from US federal contracts under proposed legislation, the contract manufacturer continued building capacity in Singapore and Ireland to keep serving Western customers from outside mainland China.

The proposed BIOSECURE Act was the immediate driver
December 2024Novo Nordisk took control of three former Catalent fill-finish plants 2 years ago

Completion of Novo Holdings' acquisition of Catalent transferred sterile fill-finish sites to Novo Nordisk, adding capacity dedicated to easing the shortage of injectable GLP-1 weight-loss and diabetes drugs.

GLP-1 demand had outstripped fill-finish capacity industry-wide
September 2024The US House Energy and Commerce Committee advanced the BIOSECURE Act 2 years ago

The bill would bar federal agencies from contracting with named Chinese biomanufacturers, including WuXi Biologics and WuXi AppTec, citing national security concerns over reliance on Chinese-made biologics.

The measure was left out of the year-end defence authorisation bill
August 2024India approved its BioE3 policy to build domestic biomanufacturing hubs 2 years ago

The Cabinet-approved Biotechnology for Economy, Environment and Employment policy set out support for bio-based chemicals, bioplastics and biopharmaceuticals, aiming to build regional biomanufacturing hubs and cut import dependence.

July 2024Ginkgo Bioworks cut roughly a third of its workforce 2 years ago

The synthetic biology and foundry company restructured as pandemic-era biosecurity revenue fell away, narrowing its focus toward cell engineering services and away from broader platform ambitions.

May 2024Florida banned the sale of cultivated meat 2 years ago

The state became the first in the US to prohibit sale of lab-grown meat outright, a move other states followed, complicating the commercial path for cultivated-protein biomanufacturers.

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