A single-use bioreactor (S.U.B) or disposable bioreactor is a bioreactor with a disposable bag instead of a culture vessel made from stainless steel or glass, a single-use bioreactor is equipped with a disposable bag. The disposable bag is usually made of a three-layer plastic foil.

Many mammalian cell based biotech producers are moving to single use bioreactor modules leveraging the advantages of single use bioreactors.

• Single-use bioreactors use stirrers like conventional bioreactors, but with stirrers that are integrated into the plastic bag.The closed bag and the stirrer are pre-sterilized. In use the bag is mounted in the bioreactor and the stirrer is connected to a driver mechanically or magnetically. 

• Single-use bioreactors are agitated by a rocking motion. This type of bioreactor does not need any mechanical agitators inside the single-use bag.

Single Use Bioreactor – Agitated Type

Advantages:

1. Eliminates validation issues because the cleaning process is avoided. 
2. Shortens downtime and turnaround time because no cleaning is required. 
3. Lowers risk of cross-contamination with use of new bags for each run. 
4. Offers multiple advantages based on the elimination of the cleaning process. 
5. Decreased operating costs and capital investment: savings on start-up capital costs as well as utilities, space, and labor requirements. 
6. Cost savings from reduced cleaning needs: less space and stainless steel equipment needed; decreased cleaning validation and decreased use of WFI and cleaning solutions; cleaning and sterilization of bioreactors or process tanks can be ‘outsourced’ to disposable bag suppliers. 
7. Elimination of the design elements of traditional stainless steel vessels that are dictated by CIP and SIP requirements: validation is reduced because systems are less complex. 
8. Ease of installation. 
9. Ease of moving when empty. 

Disadvantages:

1. Limitation in liquid transfer. 
2. Scalability is an issue: larger-scale bioreactor bags are needed than are available. 
3. Expensive to use:repetitive purchases required. 
4. Performance is not completely proven: new technology. 
5. Slight increase in variable costs per run 
6. Disposable bag systems difficult to justify for dedicated products or greater than 10,000L bioreactor scale processes. 
7. Most of the larger scale facilities already have the investment in the ground for the tanks and the required cleaning validations to support multiple product use. 
8. Leachables and inability to store hot liquids. 
9. Potential for puncture. 
10. Difficulty in moving when full. 
11. Pressure and temperature sensitivity. 
12. Disposal costs. 

Progress for Single Use Bioreactor

• Wide acceptance of bioprocess bags 
• Single use bioreactors are scalable and performance is comparable to Stainless Steel bioreactors. 
• 1000L Bioreactor scales can open up opportunitiesin commercial applications. 

List of Commercially available Single Use Bioreactor Systems

• XDR – Xcellerex 
• Mobius – Millipore 
• CelliGen BLU – eppendorf 
• Hyclone S.U.B – Thermo Scientific 
• Single Use Bioreactor – Applikon 

Got something to say about this post? Leave a comment…your comments are valuable for improving the posts.