Developing an approach to evaluate the use of neoplastic cells as vaccine substrates.
Advances in technology, emerging infectious diseases and accumulating knowledge of the mechanisms of neoplastic development are stimulating the need to develop a regulatory management plan that can be used to evaluate different types of neoplastic cells as possible substrates for vaccine development. To address this challenge, CBER is developing an approach, based on issue identification, issue-based model development and validation, and, where possible, a quantitative risk evaluation, as a basis for regulatory guidance on the use of neoplastic cell substrates for the manufacture of viral vaccines. The issues or concerns that have been identified with the use of neoplastic cell substrates include vaccine contamination with viable human tumour cells or adventitious agents, the possible risks associated with residual cell-substrate DNA or proteins in the vaccine, possible vaccine virus interactions with the cell substrate, and possible uncertainties associated with the instability of the neoplastic cell genome.
Lewis
A M
AM
Division of Viral Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD 20892, USA.
D009369:Neoplasms / Q000473:pathology*; D014407:Tumor Cells, Cultured; D014481:United States; D014486:United States Food and Drug Administration; D014765:Viral Vaccines
D014765:Viral Vaccines