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. Commercially relevant bioprocesses will:
1) produce products that maintain all of the quality standards of biopharmaceutical drugs http://www.fda.gov/cber/gdlns/cmcsomcell.pdf
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.
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Famous quotes containing the word cell:
“She that but little patience knew,
From childhood on, had now so much
A grey gull lost its fear and flew
Down to her cell and there alit,
And there endured her fingers’ touch
And from her fingers ate its bit.”
—William Butler Yeats (1865–1939)