Assessing alternate sparger configurations to mitigate supply chain risks in single-use bioreactors
March 20 – 23, 2022
Consumable shortages throughout the pandemic introduced unanticipated challenges for continued manufacture of commercial biologics. With single-use systems, the bioreactors themselves are consumables that were impacted by these supply chain shortages. To ensure patient supply of necessary biologics, risk mitigation planning and determining suitable alternatives was required. In this presentation, we detail work performed to allow for continued manufacturing, while facing stock-out risks for single-use bioreactor bags used at both the seed and production stages. Specifically, this work focused on alternate sparger configurations, as the standard configuration used in the production bioreactor stage was unavailable. Additional options for added flexibility at the seed bioreactor stages were evaluated to address stock-out risks, and are discussed.
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Stephanie Ketcham, Alexandra N Tsoras, Calvin Leung, Michael DiFiore, Susan Egan, Jianlin Xu, Jeffrey Savard, C Eric Hodgman, and Amanda M. Lewis, "Assessing alternate sparger configurations to mitigate supply chain risks in single-use bioreactors" in "Single-Use Technologies V: Building The Future", Magali Barbaroux, Sartorius, France; Martina Micheletti, University College London, UK Eds, ECI Symposium Series, (2022). https://dc.engconfintl.org/sut_v/4