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Updated: Jul 31, 2026
Stereotactic Adoptive Transfer of Cytotoxic Immune Cells in Murine Models of Orthotopic Human Glioblastoma Multiforme Xenografts
Published on: September 1, 2018
Administration of tumor cell chromatin to immunosuppressed and non-immunosuppressed non-human primates
D E Wierenga1, J Cogan, J C Petricciani
1Pharmaceutical Research and Manufacturers of America, Washington, DC, USA.
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(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.
Insights
Residual DNA in vaccines poses no neoplastic risk. Studies show injecting monkeys with human tumor cell line DNA did not cause cancer, even in immunosuppressed animals, supporting the safety of continuous cell lines for biological product manufacturing.
Area of Science:
- Biotechnology and Pharmaceutical Sciences
- Molecular Biology and Toxicology
- Vaccine Development and Safety
Background:
- Concerns exist regarding theoretical risks of contaminants from cell substrates used in biological product manufacturing.
- Residual DNA is a potential impurity that requires safety assessment for biological products.
Purpose of the Study:
- To evaluate the potential neoplastic risk of residual DNA from a human tumor cell line.
- To assess the safety of using continuous cell lines for producing biological products.
Main Methods:
- Injected normal and immunosuppressed monkeys with 10(8) genome equivalents of DNA from a human tumor cell line.
- Monitored animals for over eight years for any evidence of neoplastic disease.
Main Results:
- No animals in the study developed neoplastic disease after more than eight years of observation.
- The study found no evidence of cancer formation attributable to the injected residual DNA.
Conclusions:
- The theoretical risks associated with residual DNA from continuous cell lines are minimal.
- The benefits of using continuous cell lines for biological product manufacturing outweigh the theoretical risks of DNA impurities.
- Clinical experience and study results support the safety of approved products derived from continuous cell lines.
