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Potential oncogenic hazards posed by oncogene encoded proteins
1Laboratory of Cellular Oncology, National Cancer Institute, Bethesda, Maryland 20892.
Abstract:
The theoretical risk from oncogene encoded proteins is limited to growth factors, which may be secreted by cells in which biologically derived products might be manufactured. Because these peptides do not replicate, their effect is finite. In addition, their effects are reversible. Growth factors do not ordinarily appear to be oncogenic. Even under circumstances in which they contribute to oncogenicity, repeated administration of high concentrations of growth factors (several micrograms per kilogram) would appear to be required for them to serve as co-factors in the carcinogenic process, and the resulting tumors appear to remain dependent upon the continued presence of the growth factor for continued tumor growth.
Insights
Oncogene-encoded growth factors pose minimal theoretical risk in biologic manufacturing. Their finite, reversible effects and limited oncogenic potential, even at high doses, suggest a low risk profile for therapeutic applications.
Area of Science:
- Biotechnology and Biologics Manufacturing
- Molecular Oncology
- Risk Assessment in Therapeutics
Background:
- Biologically derived products may be manufactured using cells secreting oncogene-encoded proteins.
- Oncogene-encoded proteins, particularly growth factors, are a theoretical concern in this context.
Purpose of the Study:
- To evaluate the theoretical risks associated with oncogene-encoded growth factors in biologic manufacturing.
- To assess the oncogenic potential and reversibility of growth factor effects.
Main Methods:
- Theoretical risk assessment based on the known properties of growth factors.
- Analysis of growth factor characteristics: replication, effect duration, and dose-dependency.
Main Results:
- Growth factors, unlike replicating viruses, have finite and reversible effects.
- Ordinarily, growth factors are not oncogenic.
- Significant concentrations (micrograms per kilogram) and repeated administration are required for growth factors to act as co-factors in carcinogenesis.
- Tumors induced with growth factors appear dependent on continued growth factor presence.
Conclusions:
- The theoretical risk from oncogene-encoded growth factors in biologic manufacturing is limited.
- Growth factors exhibit finite, reversible effects and low intrinsic oncogenicity.
- The conditions required for growth factors to contribute to oncogenesis are specific and likely not met in standard manufacturing processes.