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Related Experiment Videos

Potential oncogenic hazards posed by oncogene encoded proteins.

D R Lowy1

  • 1Laboratory of Cellular Oncology, National Cancer Institute, Bethesda, Maryland 20892.

Developments in Biological Standardization
|January 1, 1987
PubMed
Summary

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.

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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.

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