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Recording: Toxicology for the 21st Century: What is in the Box for Excipients?

Recording from Wednesday, July 8, 2020

The limitations of animal-based toxicology to predict human health threats are widely recognized. We also are discovering more shortcomings of traditional (human) cell culture such as cell identity, differentiation, genetic stability and mycoplasma infection as well as non-homeostatic and non-physiological culture conditions. The increasing pace of technological developments of modern cell culture and their integration leads to what is called “disruptive technologies” that can lead to the development of alternatives to traditional approaches for product development and safety assessment.

Such technological advances promise to be real “game-changers”. Combined with an increased mechanistic base of reasoning (e.g. Adverse Outcome Pathway concepts), Integrated Testing Strategies and evidence-based methods of data evaluation and integration, a revolutionary change for how we assess the biological effects of substances has been set into motion.

Learning Objectives

> Illustrate the limitations of animal-based toxicology to predict human safety
> Describe the benefits of “disruptive technologies” on product development and safety assessment
> Explore specific examples of emerging technologies and their impact on standardization and reproducibility