Command and Control Your Bioprocess
The stem cell industry needs to embrace bioprocess control systems to develop consistent, high quality, and commercially viable bioprocesses.
Philipp Nold |
The challenge in stem cell bioprocessing – as in any industrial bioprocesses – is developing a commercially viable process that delivers products in high, consistent quality. It’s fair to say, however, that the protocols for stem cell expansion and differentiation are often significantly less mature than in biologics bioprocessing.
If we consider the medium composition, for example, cell-based therapy manufacturing requires xeno-free media to meet regulatory demands and allow process standardization. It also requires growth factors or chemical substitutes for them – at an affordable price. Another challenge is keeping commercial-scale manufacturing in mind during early-stage process development. David Courtman from the Ontario Institute for Regenerative Medicine hit the nail on the head when he said, “If I make a drug, it’s a chemically defined product and I know exactly what it is. […] In contrast, cell therapy products are really only defined by their process because the product can never fully be characterized. So the better you are at defining your process, the better you are at getting a standardized product and meeting regulatory approval” (1). Courtman’s words underline the importance of comprehensively understanding
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- Expression, “A short guide to cell therapy manufacturing, part 2”, (2018). Available at: bit.ly/2DXCn6T.
- Kropp et al., “Impact of Feeding Strategies on the Scalable Expansion of Human Pluripotent Stem Cells in Single-Use Stirred Tank Bioreactors”, Stem Cells Transl Med, 5, 1289–1301 (2016). PMID: 27369897.