# Single-use bioprocessing systems

Source: https://onco.cc/technologies/single-use-bioprocessing/  
OnCo record `single-use-bioprocessing` (Technology). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Modern biologics plants grow cells in giant sterile plastic bags instead of steel tanks, throwing the bag away after each batch. It makes plants faster to build and switch, but it ties the whole industry to a few bag and filter makers.

## Summary

Single-use systems replace stainless steel bioreactors, mixing vessels, tubing and filters with pre-sterilised disposable assemblies made of multilayer polymer films, sterilised by gamma irradiation from cobalt-60 sources (a link to the same isotope supply chain that serves radiotherapy). A 2,000-litre single-use bioreactor needs no cleaning or steam-in-place validation, so a plant can change product in days and be built in about half the time of a stainless facility; most cell therapy, viral vector and clinical-scale antibody manufacture, and a growing share of commercial antibody production, now runs this way. The trade-offs are film extractables and leachables (tested under industry protocols), per-batch consumable cost, plastic waste and a practical ceiling of a few thousand litres per bag.

The supply base is concentrated: Sartorius, Cytiva, Thermo Fisher and Merck KGaA make most bags, films and filters, and the film itself often comes from one extruder. During the COVID-19 vaccine build-out in 2020 to 2022 lead times for bags and filters stretched past a year and cancer drug makers competed for the same components, an episode that regulators and industry groups now cite when they argue for dual sourcing and standardised connectors.

## Fields

- Kind: Technology
- Status: established
- Last checked: 2026-09-17
- Tags: manufacturing-wave
- Principle: Pre-sterilised disposable process contact surfaces remove cleaning and cross-contamination steps at the cost of consumable supply dependence.
- Since: 2005
- Strengths: Fast changeover and faster plant build; Lower contamination risk between products; Scales down well for cell and gene therapy
- Limitations: Few suppliers of films and filters; Consumable lead times spike in a crisis; Volume ceiling and plastic waste

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Single-use_bioreactor
- BioPhorum: single-use systems: https://www.biophorum.com/

## Connected records

- fronts: [Antibody-Drug Conjugates](https://onco.cc/fronts/adcs/), [Cell Therapy](https://onco.cc/fronts/cell-therapy/), [Immunotherapy](https://onco.cc/fronts/immunotherapy/)
- technologies: [Antibody manufacturing (CHO bioprocessing)](https://onco.cc/technologies/monoclonal-antibody-manufacturing/), [Autologous CAR-T manufacturing, batch by batch](https://onco.cc/technologies/car-t-manufacturing-process/), [Closed automated cell-therapy manufacturing](https://onco.cc/technologies/closed-automated-cell-manufacturing/), [Downstream purification (Protein A capture, viral clearance, polishing)](https://onco.cc/technologies/downstream-purification-chromatography/), [mRNA and lipid nanoparticle manufacturing](https://onco.cc/technologies/mrna-lnp-manufacturing/), [Viral vector manufacturing (lentiviral, retroviral, AAV)](https://onco.cc/technologies/viral-vector-manufacturing/)
- companies: [Cytiva (Danaher)](https://onco.cc/companies/cytiva/), [Merck KGaA (EMD Serono)](https://onco.cc/companies/merck-kgaa/), [Nordion (Sotera Health)](https://onco.cc/companies/nordion/), [Sartorius](https://onco.cc/companies/sartorius/), [Thermo Fisher Scientific](https://onco.cc/companies/thermo-fisher/)

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