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bioprocess : ウィキペディア英語版
bioprocess

A bioprocess is a specific process that uses complete living cells or their components (e.g., bacteria, enzymes, chloroplasts) to obtain desired products
Transport of energy and mass is fundamental to many biological and environmental processes. Areas, from food processing to thermal design of building to biomedical devices to pollution control and global warming, require knowledge of how energy and mass can be transported through materials (mass, momentum, heat transfer}.
==Cell Bioprocessing==
Cell Therapy Bioprocessing is a discipline that bridges the fields of Cell Therapy and Bioprocessing (i.e. biopharmaceutical manufacturing), and is a sub-field of Bioprocess Engineering. The goals of Cell Therapy Bioprocessing are to establish reproducible and robust manufacturing processes for the production of therapeutic cells.〔Kirouac, D. and Zandstra, P. The systematic production of cells for cell therapies. Cell Stem Cell 3, October 9, 369-381, 2008〕〔Rowley, J.A. Developing Cell Therapy Biomanufacturing Processes, Chem Eng Progress, SBE Stem Cell Engineering Nov Supplement, 50-55, 2010.〕 Commercially relevant bioprocesses will:
1) produce products that maintain all of the quality standards of biopharmaceutical drugs〔Draft Guidance : Instructions and Template for CMC Reviewers of Human Somatic Cell Therapy IND Applications〕
2) supply both clinical and commercial quantities of therapeutic cells throughout the various stages of development. The processes and production technologies must be scalable,〔 and
3) control the Cost of Goods (CoGs) of the final drug product. This aspect is critical to building the foundation for a commercially viable industry.

抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)
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