Introduction to biomanufacturing / Mark F. Witcher -- Product-process-facility relationship / Jeffery Odum -- Regulatory considerations of biomanufacturing facilities / Kip Priesmeyer -- Biopharmaceutical facility design and validation / Jeffery Odum -- Closed systems in bioprocessing / Jeffery Odum -- Aseptic manufacturing considerations for biomanufacturing facility design / Jeffery Odum, Hartmut Schaz, and Larry Pressley -- Facility control of microorganisms : containment and contamination / Jonathan Crane -- Process-based laboratory design / Henriette Schubert and Flemming K. Nielsen -- Case study : pharmaceutical pilot plant design and operation / Beth H. Junker -- Addressing sustainability in biomanufacturing facility design / Josh Capparella, Samuel Colucci, Daniel Conner, Robert Dick, and Amanda Weko -- Technology's impact on the biomanufacturing facility of the future / Jeffery Odum and Mark F. Witcher. |