Animal Cell Biotechnology 2014
DOI: 10.1515/9783110278965.455
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6.3 Industrial Cell Culture Process Scale-up Strategies and Considerations

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Cited by 3 publications
(2 citation statements)
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“…Through the course of bioprocess development and final commercial production, the process has to be properly scaled to avoid late‐stage campaign failure. However, mammalian scale‐up is still challenging and deviations between the small‐scale and large‐scale performances nowadays have been mostly attributed to unavoidable inhomogeneities in large‐scale . One prominent example are pH gradients which can occur due to base or feed addition, resulting in a serious scale‐up problem .…”
Section: Introductionmentioning
confidence: 99%
“…Through the course of bioprocess development and final commercial production, the process has to be properly scaled to avoid late‐stage campaign failure. However, mammalian scale‐up is still challenging and deviations between the small‐scale and large‐scale performances nowadays have been mostly attributed to unavoidable inhomogeneities in large‐scale . One prominent example are pH gradients which can occur due to base or feed addition, resulting in a serious scale‐up problem .…”
Section: Introductionmentioning
confidence: 99%
“…To meet the increased demand for recombinant therapeutics, many of the early, low-titer processes for mAbs required bioreactor capacities of greater than 10,000 L, causing manufacturers to invest heavily in increasing production capacity. Large-scale manufacturing facilities were constructed throughout the 2000s, including facilities with bioreactor sizes ranging from 10,000 L to 25,000 L and total capacities up to 200,000 L (75). By 2009, manufacturers were routinely achieving mAb titers of 1-5 g/L from 7-14-day fed-batch processes (76).…”
Section: Upstream Process Development: Increasing Culture Scale and T...mentioning
confidence: 99%