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Technology · Bioproduction & equipment / Upstream & bioreactors

Single-use bioprocessing & modular factories

Disposable bioreactors, bags and tubing plus modular factories (KUBio — 12–18 months vs 5–7 years) cut capex and cross-contamination, making biomanufacturing flexible and multi-product.

Maturity 6/9 Risk: low Bioprocess equipment US · CN · EU Science: why it works → verified 2026-06-18 · 0 Sources (0 independent)

1 · What it gives

Single-use bioprocessing (SUS) is biomanufacturing on disposable components: bioreactors (up to 5,000 L), bags, tubing, filters and sensors. Sterile plastic systems are supplied ready for a single use and discarded after the run, eliminating CIP/SIP cleaning and cross-contamination between products. Combined with modular factories (Cytiva KUBio — assembly from ready block modules in 12–18 months versus 5–7 years for a traditional plant), SUS radically cuts capex and time-to-market, making capacity flexible across multiple products.

Key directions of single-use bioprocessing:

  1. Single-use bioreactors (Single-Use Bioreactors): bag SUBs up to 2,000–5,000 L (DynaDrive).
  2. Single-use downstream (Single-Use Downstream): closed filtration/chromatography (Allegro).
  3. Modular factories (Modular Factories): ready block GMP plants (KUBio).
  4. Films and sensors (Films & Sensors): multilayer films (Flexsafe, Aegis5-14) + single-use optical sensors.

Sectoral value chain#

[films/bags] ──> [SUB bioreactor] ──> [single-use purification] ──> [fill]
                       │
                (no CIP/SIP)
                       │
                       ▼
[product] <─── [single-use harvest] <─────┘

Value chain levels#

LevelDescriptionKey inputs/outputs
Media Prep (SUB)media preparation in single-use bagsIn: powders, WFI. Out: media.
Upstream (SUB)cell growth in a single-use bioreactorIn: media, cells, gases. Out: supernatant.
Harvest (Single-Use)single-use depth filtrationIn: supernatant. Out: liquor.
Downstream (Single-Use)single-use chromatography/TFFIn: liquor. Out: pure product.
Formulation (SUB)UF/DF in single-use cassettesIn: pure product. Out: formulation.
Aseptic Fill-Finishsterile fill in SUS linesIn: formulation. Out: drug product.

Cross-cutting technologies of the sector:

  • Multilayer films (Multilayer Films): Flexsafe/Aegis5-14 — mechanical strength and low E&L.
  • Single-use optical sensors (Single-Use Sensors): minimise signal drift over long fermentations.
  • Modular factories (Modular Factories): KUBio — block assembly with pre-installed equipment.

2 · What it replaces 3 · matched by industry

D1E–Fermentation (stainless and single-use bioreactors, solid-state reactors) and downstream equipment (centrifuges, filtration, spray and fluid-bed drying, formulation) for local production of enzymes, microbial products and fermentation ingredients instead of chemical-synthesis plants and imports
Replaces: Chemical-synthesis routes and imports for the products in FI-, FD-, I- and A-series articles (enzymes, organic acids, vitamins, microbial …
EAC
D1E4On-farm and regional biofactories (multiplication units, media, quality control) for microbial bio-inputs — Bacillus, Trichoderma, Beauveria, Bt, beneficial insects — instead of importing finished chemical pesticides and fertilizers
Replaces: Imported finished synthetic pesticides and part of mineral fertilizer programmes; also imported finished biologicals with long cold chains
EAC
D1E3Process equipment for residue-to-product plants — anaerobic digesters and biogas upgrading, composting turners and granulation lines, biomass pelleting, pyrolysis and carbonization kilns — instead of incinerators, landfill, open lagoons and open burning
Replaces: Landfill and open dumping of organic waste; open burning of crop residues; open anaerobic lagoons; incineration of wet organic waste
EAC

3 · How to implement 6 steps

  1. 1
    Media prep
    Media is prepared in single-use bags from powders and WFI.
  2. 2
    Upstream (SUB)
    Cells grow in a single-use bioreactor to target titer; no CIP/SIP is required.
  3. 3
    Harvest
    Single-use depth filtration separates cells without open steps.
  4. 4
    Downstream (SUS)Purification & downstream
    Single-use chromatography and TFF in closed circuits (Allegro).
    Who can do this step matched automatically
    Esco Aster Singapore
    ✓ ISO 9001 5,000 L industrial scale
    “Adherent cell culture and downstream processing: commercialized Tide Motion bioreactor platform (MiniTide to TideXcell) with closed automated cell harvesting and single-use …”
    Advanced Enzyme Technologies (NSE) India
    ✓ ISO 9001 500 m3
    “Development of robust, scalable fermentation and downstream processing (production and recovery/yield optimization).”
    Tsukishima Kikai Japan
    ✓ ISO 9001
    “Crystallization and refining: In-house developed DP Crystallizer and Oslo Crystallizer for tailored crystallization and refining processes; integrated purification units combining …”
  5. 5
    FormulationFormulation & blending
    UF/DF in single-use cassettes concentrates the product and transfers it into formulation.
    Who can do this step matched automatically
    Advanced Enzyme Technologies (NSE) India
    ✓ ISO 9001 500 m3
    “This is a satellite blending, mixing and formulation facility, located at Vashind near Shahapur and dedicated to the company’s Animal Nutrition business.”
    Rossari Biotech (NSE) India
    ✓ ISO 9001 industrial scale
    “The company also announced a new greenfield blending facility in Thailand to boost Southeast Asia operations and smarter capacity utilization across its HPPC, TSC, and AHN …”
    Thai Wah Thailand
    10,000 tons
    “Premix Factory in Jiaxing, China, to develop and produce premixes for bakery, dim sum, coatings, and texturizers, with 10,000 tons annual capacity, signaling a shift toward …”
  6. 6
    Fill-finish (SUS)Packaging & fill-finish
    Sterile filling in SUS lines under Annex 1; the batch goes to QC release.
    Who can do this step matched automatically
    Pakka (ex-Yash Pakka) India
    1940 MT per annum industrial scale
    “Pakka Limited (located in Ayodhya, India) provides regenerative packaging solutions for food products.”
    RWDC Industries Singapore
    industrial scale
    “2026-04-02 [A Major Step Forward in the Fight Against Microplastics — RWDC Industries is positioning itself as a leader in sustainable biopolymers, specifically Solon PHA, a fully …”

4 · Who delivers

Matched suppliers (matched automatically)

SartoriusGermanyProduceractive
UnibioDenmarkProduceractive
PBS BiotechUnited StatesServices / consultingactive

In the services and supply catalogue 2 · paid service

Upstream — fermentation & cell culture · Single-use assemblies & bags

Leading companies and institutes (from the brief)

Company / InstituteCountryKey products / platformsTech featuresStatus 2026
Sartorius🇩🇪 GermanyBiostat STR, Flexsafeintegrated SUS sensorsCommercial
Cytiva🇺🇸 USAKUBio™, Xcellerex™modular GMP factoriesCommercial
Thermo Fisher🇺🇸 USADynaDrive™, Aegis5-14cubic SUB up to 5,000 LCommercial
Merck KGaA🇩🇪 Germanymodular cleanroomsMobius SUS solutionsCommercial
Pall🇺🇸 USAAllegro™ downstreamclosed SUS circuitsCommercial
Truking🇨🇳 ChinaSUS bioreactors, fill-finishSUS equipment localisationCommercial

5 · Rules & route to market

Route into Russia / EAEU: EAC · EAEU accredited bodies / Rosakkreditatsiya
declaration registered within 3 working days (testing extra); certification longer
Information, not legal advice — confirm the procedure for your product. (2026-10-06)
United States

The US leads on SUS films, sensors and large-scale SUBs.

Thermo Fisher, Pall, Merck Millipore SUS technologies#

  • Thermo Fisher (HyClone): Aegis5-14 films, DynaDrive bioreactor up to 5,000 L.
  • Pall / Merck Millipore: closed downstream SUS systems (Allegro).
  • FDA: support for flexible capacity and accelerated technologies.
European Union

The EU is home to the leading SUS suppliers (Sartorius, Merck KGaA) and the KUBio concept.

Sartorius, Merck KGaA, Cytiva KUBio#

  • Sartorius Stedim: Biostat STR bioreactors, Flexsafe films — global SUS leader.
  • Merck KGaA: modular cleanrooms and Mobius SUS solutions.
  • Cytiva KUBio: standardised block GMP factories assembled in 12–18 months.
China

China is actively localising SUS components and building modular biopharma factories.

Truking, modular biopharma build-out, NMPA#

  • Truking: domestic SUS bioreactors and fill-finish lines.
  • Modular factories: rapid SUS-capacity rollout for biosimilars.
  • NMPA: harmonising SUS standards with GMP.

6 · Money: tenders & grants

No open tender or grant matched right now.

7 · Tech stack & innovations

The stack rests on disposable materials, sensors and modularity.

  1. Single-use bioreactors (Single-Use Bioreactors):
    • bag SUBs up to 2,000–5,000 L; DynaDrive’s cubic shape improves mixing.
  2. Multilayer films (Multilayer Films):
    • Flexsafe/Aegis5-14 — low extractables & leachables, stable cell growth.
  3. Modular factories (Modular Factories):
    • KUBio — block assembly in 12–18 months versus 5–7 years for traditional builds.

Sources 0 · 0 independent · 0 producer sites