Automation and sector-wide collaboration will be critical as developers try to move beyond the production challenges that slow growth of the cell and gene therapy sector. So says Julie G. Allickson, PhD, director of Mayo Clinic’s Center for Regenerative Biotherapeutics who argues that, despite considerable investment in infrastructure, production is still the biggest challenge.
“Both industry and academia are challenged by the lack of manufacturing capacity for cell and gene therapies,” she says, citing plasmid production and viral vector production as examples. “Besides these issues, the scalability of production processes can be difficult, especially when coupled to individually expanded cells. When looking at the patient cells variability, quantity and quality of cells is critical to ensure consistency in the product delivered to the patient,” she says.
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