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Scales up to 20,000L, which are larger capacities. Allows for higher generation of product.

More popular (used by more, is relatively old, so it is more widespread and more understood.)

Reference: https://www.cytivalifesciences.com/en/us/news-center/single-use-or-stainless-steel-bioreactors-10001

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Single-use vs stainless-steel bioreactors - Cytiva

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We look at the differences between single-use and stainless-steel bioreactors, including the pros and cons of each when used in the biopharmaceutical industry.

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In theory, both bioreactors have their advantages and disadvantages to justify why they are better in certain aspects and circumstances. However, I would suggest that disposable bioreactors are better, especially for research, biopharmaceutical production and HTS.

Disposable bioreactors are more often preferred than Fixed-in-place stainless steel bioreactors for smaller-scale production because they are more flexible, allowing frequent variability in the production volume, or the cell line used, etc.; which would be more suited to the ever-evolving research and process needs as well as development.

Furthermore, disposable bioreactors have faster turnaround time between batches so it eliminates their need for expensive and intrinsic automation to clean and sterilize the bioreactor; Clean-in-place and sterilize-in-place procedures.

Moreover, disposable systems have reduced the risk of cross-contamination between batches since they use single-use components and the bioreactor is sterilized before each batch run. This would, therefore, prevent the introduction of any unwanted microorganisms in the product and ensure quality and safety. Even now as it stands, there has been a steadily growing trend in the biopharmaceutical industries using disposable systems for biologics production for personalized medicine.

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Author links open overlay panel D. Pollard ∗ , C. Kistler

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Abstract

Applying disposable, single-use bioreactors to bioprocessing has triggered a revolution of change to traditional stainless-steel bioprocess workflow. Single use provides a cheaper, faster, and lower-cost solution than stainless steel. Single-use bioreactors have been successfully applied in discovery and preclinical biopharma applications to speed process development and material generation. The combination of continually rising upstream titers with improved single-use technology robustness is driving the expansion of single-use bioreactors into commercial manufacturing. This enables the strategy for future modular facilities with a scale-out rather than scale-up approach. Despite this success, a range of ongoing challenges is being targeted by the industry single-use community, including lowering the supply chain risk, standardizing testing protocols, expanding plug-and-play capability, improving sensor systems, and lowering bag failure. Improving these issues in coming years will reduce the barriers to single-use bioreactor implementation and continue to broaden expansion into commercial biologics, vaccines, and cell therapy manufacturing.

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Applying disposable, single-use bioreactors to bioprocessing has triggered a revolution of change to traditional stainless-steel bioprocess workflow. ...

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High utility cost

Leakage from piping tubes

Difficulties in cleaning and maintenance, require regular maintenance to ensure proper functioning.

Despite rigorous cleaning procedures, there is always a risk of cross-contamination between different batches or products, especially if the bioreactor is used for multiple processes.

Designed for specific volumes and processes. They may not be easily adaptable to changes in scale or modifications to the bioprocess.

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The Great Debate: Stainless Steel Versus Single Use

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Will single use systems win out over stainless steel? Or is a hybrid approach best?

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product limitation

- not always suitable for large scale manufacture

- limitation in liquid transfer

- temperature and pressure sensitivity

- damage to single-use bags (puncture) can impose leakage

requires ongoing consumables usage forecast

quality by design needs to consider extractables and leachable studies' data

relatively new technology - workforce skills gap

places more responsibility on the operators (quality control and cleaning)

expensive

- slight increase in variable costs per run

- disposable costs

references:

https://youtu.be/eAtg47Fr4XU?si=TkUBRvZIUlZm4BaY

https://www.pharmtech.com/view/pros-and-cons-single-use-bioreactors

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speed and ease of deployment

- ease of installation, and moving

- cleaning and validation requirements reduced

cleaning process is avoided

- eliminates validation issues

- shortens downtime/turnaround time

lowers risk of contamination

fast changeover resulting in greater batches

- new bags for each run

reduced capital expenditure for equipment and facility

- savings on start-up capital costa, utilities, space, labour and cleaning requirements

increase plant flexibility

references:

https://youtu.be/eAtg47Fr4XU?si=TkUBRvZIUlZm4BaY

https://www.pharmtech.com/view/pros-and-cons-single-use-bioreactors