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Douglas B. Hausner, PhD
Thermo Fisher Scientific
Senior Manager
Douglas B. Hausner, PhD, currently leads the solid dose continuous manufacturing program at Thermo Fisher Scientific. He has been working in the field for over a decade advocating for continuous manufacturing, publishing articles, book chapters, and participating in industry forums as well as expert groups on continuous manufacturing. Doug joined Thermo Fisher Scientific in July of 2020 after spending nearly a decade helping to lead the devel-opment of continuous manufacturing technology at Rutgers University as associate director of the NSF Engineering Research Center, C-SOPS. He has been an ISPE member since 2011.
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Innovative technologies such as continuous manufacturing (CM) bring speed, efficiency, and agility to pharmaceutical manufacturing together with enhanced process robustness and assurance of product quality. During CM, material is simultaneously charged and discharged into process unit operations. Similar to batch manufacturing, CM requires a comprehensive and holistic control strategy...
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Change in the pharmaceutical industry is notoriously slow, so it wasn't surprising that many doubted continuous manufacturing (CM) would ever be adopted. But despite the skeptics, the technology is gaining substantial ground. Since 2015, four solid oral drugs produced by continuous processes have been approved by the US Food and Drug Administration (FDA) (Table A).