Development of Assays of Defined Sensitivity for the Regulatory Management of Novel Cell Substrates.

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Zdroj: Respiratory Therapeutics Week; 3/18/2024, p916-916, 1p
Abstrakt: This document discusses the development of assays for the regulatory management of novel cell substrates used in vaccine manufacture. The focus is on transformed/tumorigenic cell substrates, which have the potential to form tumors in animals. The document highlights the challenges of ensuring the safety of vaccines manufactured in these cell substrates, including the risk of contamination with cancer-causing viruses and genetic material. The authors describe their research in understanding the process of neoplastic transformation in cells in tissue culture and evaluating the oncogenicity/infectivity of DNA from neoplastic cell substrates. They also discuss the potential use of biomarkers to study tumorigenicity and the impact of DNA degradation on the removal of oncogenic activity. [Extracted from the article]
Databáze: Complementary Index