Administration of tumor cell chromatin to immunosuppressed and non-immunosuppressed non-human primates.
For decades, developers and regulators of vaccines and other biological products have been concerned about the theoretical risk to patients posed by contaminants derived from the cell substrates used to produce those products. The present study addresses the issue of how risky DNA may be as a residual impurity by injecting both normal and immunosuppressed monkeys with 10(8) genome equivalents of DNA from a human tumor cell line. After more than eight years of observation, none of the animals shows evidence of neoplastic disease. The results of this study along with clinical experiences with already approved products derived from continuous cell lines suggest that he benefits of using such cells for the production of biologicals far outweigh any theoretical risks associated with DNA.
Wierenga
D E
DE
Pharmaceutical Research and Manufacturers of America, Washington, DC, USA.
Cogan
J
J
Petricciani
J C
JC
D000818:Animals; D002843:Chromatin / Q000276:immunology*; D004273:DNA, Neoplasm / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D006801:Humans; D016867:Immunocompromised Host; D008253:Macaca mulatta; D009369:Neoplasms / Q000209:etiology; D011323:Primates; D014407:Tumor Cells, Cultured
D002843:Chromatin; D004273:DNA, Neoplasm