# 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. Source: https://en.bioecon.ru/technology/single-use-bioprocessing/ Updated: 2026-08-18 ## Overview 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 | Level | Description | Key inputs/outputs | |:---|:---|:---| | **Media Prep (SUB)** | media preparation in single-use bags | **In:** powders, WFI. **Out:** media. | | **Upstream (SUB)** | cell growth in a single-use bioreactor | **In:** media, cells, gases. **Out:** supernatant. | | **Harvest (Single-Use)** | single-use depth filtration | **In:** supernatant. **Out:** liquor. | | **Downstream (Single-Use)** | single-use chromatography/TFF | **In:** liquor. **Out:** pure product. | | **Formulation (SUB)** | UF/DF in single-use cassettes | **In:** pure product. **Out:** formulation. | | **Aseptic Fill-Finish** | sterile fill in SUS lines | **In:** 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. --- ## US 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. --- ## CN 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. --- ## EU 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. --- ## Leading companies and research institutes | Company / Institute | Country | Key products / platforms | Tech features | Status 2026 | |:---|:---|:---|:---|:---| | **Sartorius** | 🇩🇪 Germany | *Biostat STR*, *Flexsafe* | integrated SUS sensors | Commercial | | **Cytiva** | 🇺🇸 USA | *KUBio™*, *Xcellerex™* | modular GMP factories | Commercial | | **Thermo Fisher** | 🇺🇸 USA | *DynaDrive™*, *Aegis5-14* | cubic SUB up to 5,000 L | Commercial | | **Merck KGaA** | 🇩🇪 Germany | modular cleanrooms | Mobius SUS solutions | Commercial | | **Pall** | 🇺🇸 USA | *Allegro™* downstream | closed SUS circuits | Commercial | | **Truking** | 🇨🇳 China | SUS bioreactors, fill-finish | SUS equipment localisation | Commercial | --- ## Tech 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. --- ## Value 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.