Tumorigenicity testing: past concerns, future problems.
Tumorigenicity testing has been an integral part of cell substrate characterization. With the combination of recombinant technology and traditional cell culture, we have entered an era in which many of the principles developed with vaccine production may need to be modified and new ones developed. Models of tumorigenicity are reviewed in the light of current knowledge; the applicability and necessity of such testing in new areas such as somatic cell therapy will also be presented.
Noguchi
P D
PD
Division of Biochemistry and Biophysics, Center for Biologics Evaluation and Research, Bethesda, MD 20892.
D000818:Animals; D001688:Biological Products / Q000096:biosynthesis; D002460:Cell Line; D002471:Cell Transformation, Neoplastic; D004195:Disease Models, Animal; D006801:Humans; D009368:Neoplasm Transplantation; D009374:Neoplasms, Experimental / Q000209:etiology*
D001688:Biological Products