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 residu...
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Published in | Biologicals Vol. 23; no. 3; pp. 221 - 224 |
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Main Authors | , , |
Format | Journal Article |
Language | English |
Published |
England
Elsevier Ltd
01.09.1995
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Subjects | |
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Abstract | 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
8genome 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. |
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AbstractList | 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 super(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. (DBO) 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 8genome 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. 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. |
Author | Wierenga, D.E. Cogan, J. Petricciani, J.C. |
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BackLink | https://www.ncbi.nlm.nih.gov/pubmed/8527121$$D View this record in MEDLINE/PubMed |
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CitedBy_id | crossref_primary_10_1002_btpr_1548 crossref_primary_10_1089_hum_2005_16_393 crossref_primary_10_3389_fmicb_2020_00372 crossref_primary_10_1016_j_jchromb_2006_11_018 crossref_primary_10_1016_j_yrtph_2007_10_011 crossref_primary_10_1089_aid_1998_14_627 crossref_primary_10_1007_BF02841511 crossref_primary_10_3390_microorganisms1010100 crossref_primary_10_1016_j_memsci_2018_10_058 crossref_primary_10_1586_14760584_6_4_547 |
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SubjectTerms | Animals Chromatin - immunology DNA, Neoplasm - administration & dosage DNA, Neoplasm - adverse effects DNA, Neoplasm - immunology Humans Immunocompromised Host Macaca mulatta Neoplasms - etiology Primates Tumor Cells, Cultured |
Title | Administration of Tumor Cell Chromatin to Immunosuppressed and Non-immunosuppressed Non-human Primates |
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