Cookies

Like most websites The Medicine Maker uses cookies. In order to deliver a personalized, responsive service and to improve the site, we remember and store information about how you use it. Learn more.
Manufacture Advanced Medicine, Process Control, Bioprocessing - Upstream & Downstream

Command and Control Your Bioprocess

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
your process.

Enjoy our FREE content!

Log in or register to read this article in full and gain access to The Medicine Maker’s entire content archive. It’s FREE and always will be!

Login if you already created an account

Or register now - it’s free and always will be!

You will benefit from:

  • Unlimited access to ALL articles
  • News, interviews & opinions from leading industry experts
  • Receive print (and PDF) copies of The Medicine Maker magazine
Register

Or Login as a Guest or via Social Media

  1. Expression, “A short guide to cell therapy manufacturing, part 2”, (2018). Available at: https://bit.ly/2DXCn6T.
  2. 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.

About the Author

Philipp Nold

Philipp Nold is Infield Application Specialist at Eppendorf AG Bioprocess Center.

Register to The Medicine Maker

Register to access our FREE online portfolio, request the magazine in print and manage your preferences.

You will benefit from:

  • Unlimited access to ALL articles
  • News, interviews & opinions from leading industry experts
  • Receive print (and PDF) copies of The Medicine Maker magazine

Register