If you need to move to volumes larger than 1,—2, L, you may need a hybrid solution with a single-use seed line and stainless-steel production bioreactors. The supplier's validation package is important, as is its strategy to ensure a high level of batch-to-batch consistency. Variations among supplier batches could put your own process consistency at risk. You need only electrical power, water, and gas supplies for the system. Also, because the vessel requires no sterilization or cleaning, equipment down-time can be significantly reduced. However, additional process transfer time needs consideration.
Depending on your bioreactor selection, process parameters may need to be modified before you have a robust and similar process as was established in the previous multiuse setup. Furthermore, additional process time can be linked to emptying vessels at the end of culture processes when no sterile air pressure can be used. Overall, the time saved by using SUBs is significantly more than that of multiuse processes.
Sensors: Optical, single-use sensors supplied with many SUB bags reduce the risk of contamination and limit the time needed to prepare a vessel for its next culture with no autoclaving of sensors required. When single-use sensors cannot be used for a given process, however, there is no need to base your bioreactor selection on this factor alone. For example, aseptic connections aren't automated with the former, so connections must be made manually.
Such connections are ideally realized by specific welding devices, which reduces the risk of manual errors. Sterile welding and sealing of thermoplastic tubing are key technologies that offer the highest flexibility to users who require a solution to accommodate multiple connection and disconnection cycles. So it is important to evaluate your current process set-up and exchange nonweldable tubing for suitable thermoplastic tubing wherever connections and disconnections are required. With the more fragile polymer vessel material, it becomes important to perform proper risk analysis of handling procedures.
Bag assembly and installation in a holder Photos 3 and 4 are especially important aspects to consider.
Single-Use Bioractors | olagynulehyb.gq
They become more complex with increasing vessel size. Because vaccine manufacturers work with viruses, financial risk is not the only type of risk to be considered. Biosafety risks are higher with vaccines than in recombined proteins or MAb production. SUB vendors therefore should not only be evaluated based on product performance, but also on the level of quality and robustness they offer. How can they contribute to proper biosafety risk mitigation? Such concepts are common practice in the vaccine industry, and examples of such studies specifically using single-use bioreactors can be found in the public domain 5.
During biosafety risk mitigation evaluation, vendors should be challenged in their bioreactor's means of preventing bag integrity loss. Those may include protection against sharp objects, overpressure protection, and measures against overheating.
Furthermore, they should include ways to contain an environmental contamination in case of bag damage — for example, with a containment platform installed below the bioreactor. Appropriate training and support from your selected vendor are essential to reducing risks. However, even with perfect training, we must be continually aware of risks involved in single-use. It is important to remain vigilant regarding human errors, which can lead to bag damage and consequent leaks. To mitigate the risk of damage passing undetected, HIPRA recently implemented a specific bag test developed by its selected vendor.
The device Photo 5 allows us to test bioreactor bags for leakage before use but after installation in the bag holder and after all connections are made 6.
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That allows us to verify that all connections are correctly made and no damage occurred during bag transport, storage, or installation. Implementation of the bag tester thus significantly reduces financial and biosafety risks. For this study, the following criteria were used for specific virus production to be evaluated: different continuous cell lines Vero and glioma bovine kidney, GBK ; the number of processes where these cells are involved; the number of batches of antigen produced per year.
Cell growth in the bioreactor takes four to five days, and virus replication after infection takes from two days in some processes to four days in others. Single-use bioreactors have improved dramatically since the earliest implementations. The company is also undertaking an analysis of the environmental impact and benefits of single-use bioreactors. This study goes beyond a comparative analysis of acquisition and operating costs for stainless steel and plastic to include carbon footprint, energy, and water consumption.
The worldwide capacity glut still puts off firms with large investments in stainless steel despite constant volumetric productivity improvements. Cunningham reports that at a recent meeting bioprocessors indicated a preference for running hard-piped equipment at less than full capacity, rather than switching to plastic. Log in to leave a comment.
Bioreactors for growing cells
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Next I asked Ken to summarize some of the key benefits for using single-use technologies in fermentation. He said that the benefits are largely analogous to the benefits found in cell culture applications. Primarily, reduced cost for capital equipment and the supporting utilities and piping, and reduced footprint.
Another big benefit is better equipment utilization due to reduced batch turnaround time, with no issues around product cross contamination, no CIP or validation. Lastly it supports a scale up or scale out model, which gives manufacturers a great deal of flexibility in their business model. I was curious, if I was using stainless steel tanks now, what factors would I have to consider in deciding on a move to single-use.
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He explained how to screen process requirements against the capabilities of the equipment and to look at the biomanufacturing strategy with the therapeutic product being produced. Then we talked about implementation of single-use fermentation. Ken said that from a high level, implementation looks similar to stainless steel minus some of the space requirements. Fluid management, tubing sets, tubing welders for single-use may be foreign to stainless steel users.
This means training, particularly in bag handling and other topics unique to single-use is needed.