Process economics in biologics manufacturing
September 17-21, 2017
The economics of manufacturing of therapeutic biologics are often not well understood by those tasked with developing processes for commercial production. This topic will explore the major factors influencing the process economics in bio-manufacturing, including capex investment, operational costs, technology selection as well as plant productivity and asset utilization. The interaction and sensitivities of these factors against one another, and their overall impact to the ultimate cost of goods (COGs) will be explored. This talk will explore the following topics: 1. Industry challenges and trends around bio-manufacturing 2. How COGs models are built, comparing fixed and variable cost inputs 3. How technology selection can impact the COGs outcome 4. The sensitivity of various factors to the overall COGs picture 5. What impacts that stainless steel, single use and continuous processes can have on the COGs outcome Sample cost models across multiple technology platforms will be explored to see how various technologies compare, and to see where we should be focusing our efforts to get the most cost effective manufacturing outcome for our biologics products
John Machulski, "Process economics in biologics manufacturing" in "Integrated Continuous Biomanufacturing III", Suzanne Farid, University College London, United Kingdom Chetan Goudar, Amgen, USA Paula Alves, IBET, Portugal Veena Warikoo, Axcella Health, Inc., USA Eds, ECI Symposium Series, (2017). http://dc.engconfintl.org/biomanufact_iii/61
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