The Scalability Challenge in MSC Therapies
John Yoshi Shyu on why mesenchymal stem cell programs stall – and how early manufacturing decisions can determine clinical and commercial success
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Many MSC therapy programs struggle to progress beyond early clinical stages due to donor-to-donor variability affecting efficacy.
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The choice of cell culture system significantly impacts the scalability of MSC therapies, influencing development and manufacturing processes.
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Teams often realize their MSC processes won't scale during the first true scale-up, when changes in cell biology become evident.
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Understanding cost of goods (COGS) is crucial, as early decisions can lock in cost structures that complicate later manufacturing.
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Future advancements in MSC therapies will likely involve standardized, automated systems and improved logistics for better scalability.
