Tuesday, July 16, 2013

Sources of variability in disposable bioreactors

Today, we return to Dr. Rajesh Krishnan, Associate Director of Cell Line and Upstream Process Development at Gilead Sciences Process Development Work at Gilead Sciences, podcast reported for BioProcess International. In his podcast, he looks at many aspects of single use technologies. Today, he answers the question:

What are some sources of variability in disposable bioreactors in how they perform?
Rajesh: I would say the biggest source of variability, besides potential issues with resins, would be the accuracy of process control; i.e., how well you are really controlling pH, dissolved oxygen and mixing in these different bag configurations. Process control can be impacted by many parameters, including the type of probes used (either single use or standard probes) and the design of the bag. I think that is where I’ve seen the biggest variability when I’ve done these assessments of single-use bioreactors in the past.

On the other hand, product quality variability, with material made in different single-use systems, was not really that significant in my experience.
However, another difference between single-use systems is the ease of set up and use (ex. Probe insertion into bags, placement of bags into the holders, etc). This does not really lead to process variability, but it can impact facility fit of the different bioreactors.

To hear Dr. Krishnan's entire podcast, download it here.

Dr. Krishnan will be presenting the case study Investigation and Reduction of Performance Variability in Single-use Cell Culture Bioreactors on Thursday, September 19 at Bioprocess International Conference and Exhibition. For more information on this session and the rest of the program, download the agenda. If you'd like to join us, as a reader of this blog, when you register to join us and mention code BLOG13JP, you'll save 20% off the standard rate.

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