Single-use bioprocessing & modular factories

01Overview and value chain

Markers: [EC: EU GMP Annex 1 | OECD: Bio-Pharmaceuticals | Regulator: FDA (USA), EMA (EU), NMPA (China)]

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

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.

02US

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.

03CN

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.

04EU

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.

05Leading companies and research institutes

06Tech stack and 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.

07Value chains and production pipelines

Single-use biomanufacturing pipeline (GMP / Annex 1)

┌───────────────────────────┐      ┌───────────────────────────┐
│ 1. Media prep (SUB)       │ ───> │ 2. Upstream (SUB)         │
└───────────────────────────┘      └───────────────────────────┘
                                                 │
                                                 ▼
┌───────────────────────────┐      ┌───────────────────────────┐
│ 4. Downstream (SUS)       │ <─── │ 3. Harvest (single-use)   │
└───────────────────────────┘      └───────────────────────────┘
              │
              ▼
┌───────────────────────────┐      ┌───────────────────────────┐
│ 5. Formulation (UF/DF)    │ ───> │ 6. Fill-finish (SUS)      │
└───────────────────────────┘      └───────────────────────────┘

Stage 1: Media prep

Media is prepared in single-use bags from powders and WFI.

Stage 2: Upstream (SUB)

Cells grow in a single-use bioreactor to target titer; no CIP/SIP is required.

Stage 3: Harvest

Single-use depth filtration separates cells without open steps.

Stage 4: Downstream (SUS)

Single-use chromatography and TFF in closed circuits (Allegro).

Stage 5: Formulation

UF/DF in single-use cassettes concentrates the product and transfers it into formulation.

Stage 6: Fill-finish (SUS)

Sterile filling in SUS lines under Annex 1; the batch goes to QC release.