The BioInsights Podcast
The BioInsights Podcast: discussing the challenges of translating novel biologics from bench to clinic to market.
The BioInsights Podcast
Fit for function: developing potency assays reflective of the in vivo environment
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BioInsights
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Season 3
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Episode 7
Translating the therapeutic promise of cell and gene therapies into clinical reality relies on robust potency assays. However, designing assays that accurately reflect the complex mechanisms of these therapies can feel like chasing a moving target. Here, Charlotte Barker, Editor, Cell & Gene Therapy Insights, speaks with Giorgio Zenere, CMC technical project lead in the Global QC Technology Innovation Team, Kite Pharma, and Dirk Windgassen, Director of Analytical Development, Miltenyi Biotec, to discuss best practices and future trends in developing potency assays for cell and gene therapies.
Can you each start by introducing yourselves and telling us about what you are working on right now?
What is the latest regulatory guidance on potency assays for cell and gene therapy, and are there any areas of disharmony?
What best practices would you recommend to cell and gene therapy developers in potency assay development?