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Concurrent Session: Continuous Drug Substance Manufacturing - Coming of Age|Continuous processing (CP) has long been heralded as a breakthrough innovation for pharmaceutical processing. The approach has been actively encouraged as a route to ‘cleaner, flexible and more efficient’ processing (Dr. Janet Woodcock, FDA, AAPS Meeting, 2011). While significant progress has been made in realising this objective in drug product manufacturing, progress on its application at a large scale in drug substance / API processing has lagged expectations. This session presents the experiences of two pharmaceutical companies who have made significant investments in this area for both small and large molecule therapies. Their insights into the challenges of such processing and especially as to how the digital technologies inherent in Pharma 4.0 can enable the CP vision will form an interesting and hopefully educational final session in the 2021 Annual Meeting Agile Innovation stream.
Session Leader(s):
Thomas
F. Struble,
Director of Commissioning, Qualification, and Validation,
DPS Group
Speaker(s):
Kevin
Seibert,
PhD,
Engineering Fellow, Synthetic Molecule Design and Development,
Eli Lilly and Co