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.
Read more about this topic: Cell Therapy
Famous quotes containing the word cell:
“In America all too few blows are struck into flesh. We kill the spirit here, we are experts at that. We use psychic bullets and kill each other cell by cell.”
—Norman Mailer (b. 1923)