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An Integrated Research, Education/Training, and Industry Practice Framework to Accelerate the Innovation in Biopharmaceuticals Manufacturing and Eliminate Drug Shortage

Collection
2019 ASEE Zone I Conference & Workshop
Authors
Wei Xie; Jared Auclair; Jinxiang Pei
tothe drafting of data integrity guidance for industry (PDA, WHO) and trained governments inChina, India, Mexico, Brazil.Reference[1] J.R. Auclair, Regulatory Convergence for Biologics through Capacity Building and Training,Trends Biotechnol, 37 (2019) 5-9.[2] Cynthia A. Challener, “Improving PAT for Biologics,” BioPharm International, DOI (2017).[3] Ye Chen, Lina Mockus, Seza Orcun, Gintaras V. Reklaitis, “Simulation-optimization approachto clinical trial supply chain management with demand scenario forecast”, Computers andChemical Engineering 40 (2012) 82-96.[4] K. Dalgaard, W.-C. Garstner, From Science to Operations: Questions, Choices, and Strategiesfor Success in Biopharma, McKinsey & Company, DOI (2014).[5] FDA approval brings first
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